Diabetes Mellitus, Type 2 Clinical Trial
— THEMISOfficial title:
A Multinational, Randomised, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Ticagrelor Twice Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Stroke in Patients With Type 2 Diabetes Mellitus (THEMIS - Effect of Ticagrelor on Health Outcomes in Diabetes Mellitus Patients Intervention Study).
| Verified date | March 2020 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to compare the effect of ticagrelor versus placebo in patients with Type 2 Diabetes Mellitus.
| Status | Completed |
| Enrollment | 19271 |
| Est. completion date | January 25, 2019 |
| Est. primary completion date | January 25, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 50 Years to 130 Years |
| Eligibility |
Inclusion Criteria: Men or women =50 years of age with type 2 diabetes mellitus on treatment with a glucose lowering medication since at least 6 months, and either documented coronary artery occlusive disease or previous revascularization of a coronary artery. Key Exclusion Criteria: History of myocardial infarction or any stroke; planned treatment with agents inhibiting blood clotting; planned use of ASA/Aspirin at doses above 150 mg daily; planned coronary, cerebrovascular, or peripheral arterial revascularization; patients with known bleeding disorders and patients who need chronic oral anticoagulant therapy or chronic low-molecular-weight heparin; history of intracranial bleeding at any time, or a history of bleeding from the gastrointestinal tract within the last 6 months or a major surgery within the last 30 days; patients with known severe liver disease or with kidney failure requiring dialysis |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Research Site | Buenos aires | |
| Argentina | Research Site | Buenos Aires | |
| Argentina | Research Site | Ciudad Autónoma de Bs. As. | |
| Argentina | Research Site | Ciudad Autonomade Buenos Aires | |
| Argentina | Research Site | Ciudadela | |
| Argentina | Research Site | Cordoba | |
| Argentina | Research Site | Cordoba | |
| Argentina | Research Site | Cordoba | |
| Argentina | Research Site | Mar del Plata | |
| Argentina | Research Site | Mar del Plata | |
| Argentina | Research Site | Ranelagh | |
| Argentina | Research Site | Rosario | |
| Argentina | Research Site | Rosario | |
| Argentina | Research Site | Rosario | |
| Argentina | Research Site | San Luis | |
| Argentina | Research Site | San Miguel de Tucuman | |
| Argentina | Research Site | San Miguel de Tucuman | |
| Argentina | Research Site | San Nicolás | |
| Argentina | Research Site | Santa Fe | |
| Argentina | Research Site | Venado Tuerto | |
| Argentina | Research Site | Villa Maria | |
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| Australia | Research Site | Coffs Harbour | |
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| Australia | Research Site | Joondalup | |
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| Australia | Research Site | Merewether | |
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| Philippines | Research Site | Pasig City | |
| Philippines | Research Site | Quezon City | |
| Philippines | Research Site | Quezon City | |
| Philippines | Research Site | Taguig City | |
| Poland | Research Site | Biala Rawska | |
| Poland | Research Site | Bialystok | |
| Poland | Research Site | Bialystok | |
| Poland | Research Site | Bialystok | |
| Poland | Research Site | Bielsko-Biala | |
| Poland | Research Site | Bochnia | |
| Poland | Research Site | Bydgoszcz | |
| Poland | Research Site | Bydgoszcz | |
| Poland | Research Site | Bydgoszcz | |
| Poland | Research Site | Chojnice | |
| Poland | Research Site | Chorzów | |
| Poland | Research Site | Chrzanow | |
| Poland | Research Site | Chrzanów | |
| Poland | Research Site | Elblag | |
| Poland | Research Site | Gdansk | |
| Poland | Research Site | Gdansk | |
| Poland | Research Site | Gdansk | |
| Poland | Research Site | Gdansk | |
| Poland | Research Site | Gdynia | |
| Poland | Research Site | Gdynia | |
| Poland | Research Site | Gdynia | |
| Poland | Research Site | Gizycko | |
| Poland | Research Site | Grodzisk Mazowiecki | |
| Poland | Research Site | Jaslo | |
| Poland | Research Site | Katowice | |
| Poland | Research Site | Katowice | |
| Poland | Research Site | Katowice | |
| Poland | Research Site | Kedzierzyn Kozle | |
| Poland | Research Site | Kielce | |
| Poland | Research Site | Koscian | |
| Poland | Research Site | Koszalin | |
| Poland | Research Site | Kraków | |
| Poland | Research Site | Kraków | |
| Poland | Research Site | Kraków | |
| Poland | Research Site | Legnica | |
| Poland | Research Site | Lódz | |
| Poland | Research Site | Lubin | |
| Poland | Research Site | Lublin | |
| Poland | Research Site | Lublin | |
| Poland | Research Site | Lublin | |
| Poland | Research Site | Lublin | |
| Poland | Research Site | Mikolów | |
| Poland | Research Site | Myszków | |
| Poland | Research Site | Naklo nad Notecia | |
| Poland | Research Site | Nowogard | |
| Poland | Research Site | Nysa | |
| Poland | Research Site | Opole | |
| Poland | Research Site | Ostrów Mazowiecka | |
| Poland | Research Site | Oswiecim | |
| Poland | Research Site | Plock | |
| Poland | Research Site | Poznan | |
| Poland | Research Site | Poznan | |
| Poland | Research Site | Pulawy | |
| Poland | Research Site | Ruda Slaska | |
| Poland | Research Site | Rzeszów | |
| Poland | Research Site | Rzeszów | |
| Poland | Research Site | Siedlce | |
| Poland | Research Site | Sobótka | |
| Poland | Research Site | Sokólka | |
| Poland | Research Site | Staszów | |
| Poland | Research Site | Szczecin | |
| Poland | Research Site | Szczecin | |
| Poland | Research Site | Tarnów | |
| Poland | Research Site | Torun | |
| Poland | Research Site | Torun | |
| Poland | Research Site | Tychy | |
| Poland | Research Site | Ustron | |
| Poland | Research Site | Warszawa | |
| Poland | Research Site | Warszawa | |
| Poland | Research Site | Warszawa | |
| Poland | Research Site | Warszawa | |
| Poland | Research Site | Wierzchoslawice | |
| Poland | Research Site | Wloclawek | |
| Poland | Research Site | Wroclaw | |
| Poland | Research Site | Wroclaw | |
| Poland | Research Site | Zabrze | |
| Poland | Research Site | Zamosc | |
| Poland | Research Site | Zgierz | |
| Poland | Research Site | Zielona Góra | |
| Poland | Research Site | Znin | |
| Puerto Rico | Research Site | Canovanas | |
| Puerto Rico | Research Site | Cidra | |
| Romania | Research Site | Bacau | |
| Romania | Research Site | Bucharest | |
| Romania | Research Site | Bucharest | |
| Romania | Research Site | Bucuresti | |
| Romania | Research Site | Craiova | |
| Romania | Research Site | Craiova | |
| Romania | Research Site | Iasi | |
| Romania | Research Site | Iasi | |
| Romania | Research Site | Pitesti | |
| Romania | Research Site | Suceava | |
| Russian Federation | Research Site | Arkhangelsk | |
| Russian Federation | Research Site | Ekaterinburg | |
| Russian Federation | Research Site | Ekaterinburg | |
| Russian Federation | Research Site | Gatchina | |
| Russian Federation | Research Site | Ivanovo | |
| Russian Federation | Research Site | Izhevsk | |
| Russian Federation | Research Site | Kaluga | |
| Russian Federation | Research Site | Kazan | |
| Russian Federation | Research Site | Kazan | |
| Russian Federation | Research Site | Kazan | |
| Russian Federation | Research Site | Kemerovo | |
| Russian Federation | Research Site | Kemerovo | |
| Russian Federation | Research Site | Khanty-Mansiysk | |
| Russian Federation | Research Site | Krasnodar | |
| Russian Federation | Research Site | Krasnodar | |
| Russian Federation | Research Site | Krasnodar | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Nizhniy Novgorod | |
| Russian Federation | Research Site | Novosibirsk | |
| Russian Federation | Research Site | Novosibirsk | |
| Russian Federation | Research Site | Novosibirsk | |
| Russian Federation | Research Site | Omsk | |
| Russian Federation | Research Site | Omsk | |
| Russian Federation | Research Site | Omsk | |
| Russian Federation | Research Site | Perm | |
| Russian Federation | Research Site | Perm | |
| Russian Federation | Research Site | Perm | |
| Russian Federation | Research Site | Rostov-na-Donu | |
| Russian Federation | Research Site | Ryazan | |
| Russian Federation | Research Site | Ryazan | |
| Russian Federation | Research Site | Saint Petersburg | |
| Russian Federation | Research Site | Saint Petersburg | |
| Russian Federation | Research Site | Saint Petersburg | |
| Russian Federation | Research Site | Saint Petersburg | |
| Russian Federation | Research Site | Saint- Petersburg | |
| Russian Federation | Research Site | Saint-Petersburg | |
| Russian Federation | Research Site | Saint-Petersburg | |
| Russian Federation | Research Site | Saint-Petersburg | |
| Russian Federation | Research Site | Saint-Petersburg | |
| Russian Federation | Research Site | Saint-Petersburg | |
| Russian Federation | Research Site | Saint-Petersburg | |
| Russian Federation | Research Site | Saratov | |
| Russian Federation | Research Site | St Petersburg | |
| Russian Federation | Research Site | St. Petersburg | |
| Russian Federation | Research Site | St.Petersburg | |
| Russian Federation | Research Site | St.Petersburg | |
| Russian Federation | Research Site | StPetersburg | |
| Russian Federation | Research Site | Tomsk | |
| Russian Federation | Research Site | Tver | |
| Russian Federation | Research Site | Tyumen | |
| Russian Federation | Research Site | Tyumen | |
| Russian Federation | Research Site | Ufa | |
| Russian Federation | Research Site | Vladimir | |
| Russian Federation | Research Site | Volgograd | |
| Russian Federation | Research Site | Yaroslavl | |
| Saudi Arabia | Research Site | Dammam | |
| Saudi Arabia | Research Site | Dammam | |
| Saudi Arabia | Research Site | Jeddah | |
| Saudi Arabia | Research Site | Khobar | |
| Saudi Arabia | Research Site | Riyadh | |
| Saudi Arabia | Research Site | Riyadh | |
| Saudi Arabia | Research Site | Riyadh | |
| Saudi Arabia | Research Site | Riyadh | |
| Slovakia | Research Site | Banska Bystrica | |
| Slovakia | Research Site | Bratislava | |
| Slovakia | Research Site | Brezno | |
| Slovakia | Research Site | Kosice | |
| Slovakia | Research Site | Kosice | |
| Slovakia | Research Site | Kralovsky Chlmec | |
| Slovakia | Research Site | Liptovsky Mikulas | |
| Slovakia | Research Site | Lucenec | |
| Slovakia | Research Site | Martin | |
| Slovakia | Research Site | Nitra | |
| Slovakia | Research Site | Presov | |
| Slovakia | Research Site | Ruzomberok | |
| Slovakia | Research Site | Svidnik | |
| Slovakia | Research Site | Trnava | |
| Slovakia | Research Site | Zilina | |
| South Africa | Research Site | Alberton | |
| South Africa | Research Site | Benoni | |
| South Africa | Research Site | Bloemfontein | |
| South Africa | Research Site | Cape Town | |
| South Africa | Research Site | Cape Town | |
| South Africa | Research Site | Cape Town | |
| South Africa | Research Site | Cape Town | |
| South Africa | Research Site | Cape Town | |
| South Africa | Research Site | Cape Town | |
| South Africa | Research Site | Durban | |
| South Africa | Research Site | Durban | |
| South Africa | Research Site | Durban | |
| South Africa | Research Site | Greenbury, Phoenix | |
| South Africa | Research Site | Johannesburg | |
| South Africa | Research Site | Johannesburg | |
| South Africa | Research Site | Paarl | |
| South Africa | Research Site | Port Elizabeth | |
| South Africa | Research Site | Soweto | |
| South Africa | Research Site | Stanger | |
| South Africa | Research Site | Verulam | |
| South Africa | Research Site | Worcester | |
| Spain | Research Site | A Coruña | |
| Spain | Research Site | Alcalá de Henares | |
| Spain | Research Site | Alicante | |
| Spain | Research Site | Barcelona | |
| Spain | Research Site | Barcelona | |
| Spain | Research Site | Barcelona | |
| Spain | Research Site | Barcelona | |
| Spain | Research Site | Barcelona | |
| Spain | Research Site | Bilbao | |
| Spain | Research Site | Cáceres | |
| Spain | Research Site | El Palmar | |
| Spain | Research Site | Ferrol (A Coruña) | |
| Spain | Research Site | Girona | |
| Spain | Research Site | Granada | |
| Spain | Research Site | Hospitalet de Llobregat | |
| Spain | Research Site | Huelva | |
| Spain | Research Site | La Laguna (Tenerife) | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Majadahonda | |
| Spain | Research Site | Málaga | |
| Spain | Research Site | Móstoles | |
| Spain | Research Site | Pontevedra | |
| Spain | Research Site | Sabadell | |
| Spain | Research Site | San Juan de Alicante | |
| Spain | Research Site | San Sebastian de los Reyes | |
| Spain | Research Site | Santander | |
| Spain | Research Site | Santiago(A Coruña) | |
| Spain | Research Site | Sevilla | |
| Spain | Research Site | Sevilla | |
| Spain | Research Site | Son Ferriol | |
| Spain | Research Site | Valdemoro | |
| Spain | Research Site | Valencia | |
| Sweden | Research Site | Göteborg | |
| Sweden | Research Site | Jönköping | |
| Sweden | Research Site | Lessebo | |
| Sweden | Research Site | Lund | |
| Sweden | Research Site | Lund | |
| Sweden | Research Site | Malmö | |
| Sweden | Research Site | Örebro | |
| Sweden | Research Site | Rättvik | |
| Sweden | Research Site | Stockholm | |
| Sweden | Research Site | Stockholm | |
| Sweden | Research Site | Stockholm | |
| Sweden | Research Site | Stockholm | |
| Sweden | Research Site | Uppsala | |
| Sweden | Research Site | Västerås | |
| Taiwan | Research Site | Changhua City | |
| Taiwan | Research Site | Hsinchu | |
| Taiwan | Research Site | Hualien City | |
| Taiwan | Research Site | Kaohsiung | |
| Taiwan | Research Site | Kaohsiung | |
| Taiwan | Research Site | Kaohsiung | |
| Taiwan | Research Site | Kaohsiung City | |
| Taiwan | Research Site | Kweishan Shiang | |
| Taiwan | Research Site | New Taipei City | |
| Taiwan | Research Site | New Taipei City | |
| Taiwan | Research Site | Pingtung | |
| Taiwan | Research Site | Taichung | |
| Taiwan | Research Site | Taichung | |
| Taiwan | Research Site | Taichung | |
| Taiwan | Research Site | Tainan | |
| Taiwan | Research Site | Tainan | |
| Taiwan | Research Site | Tainan | |
| Taiwan | Research Site | Taipei | |
| Taiwan | Research Site | Taipei | |
| Taiwan | Research Site | Taipei | |
| Taiwan | Research Site | Taipei | |
| Thailand | Research Site | Bangkok | |
| Thailand | Research Site | Bangkok | |
| Thailand | Research Site | Bangkoknoi | |
| Thailand | Research Site | Chiang Mai | |
| Thailand | Research Site | Hat Yai | |
| Thailand | Research Site | Muang | |
| Thailand | Research Site | Naimuang | |
| Turkey | Research Site | Adana | |
| Turkey | Research Site | Ankara | |
| Turkey | Research Site | Ankara | |
| Turkey | Research Site | Ankara | |
| Turkey | Research Site | Antalya | |
| Turkey | Research Site | Antalya | |
| Turkey | Research Site | Aydin | |
| Turkey | Research Site | Istanbul | |
| Turkey | Research Site | Istanbul | |
| Turkey | Research Site | Istanbul | |
| Turkey | Research Site | Istanbul | |
| Turkey | Research Site | Istanbul | |
| Turkey | Research Site | Mersin | |
| Ukraine | Research Site | Belo Horizonte | |
| Ukraine | Research Site | Cherkasy | |
| Ukraine | Research Site | Dnipro | |
| Ukraine | Research Site | Dnipro | |
| Ukraine | Research Site | Dnipro | |
| Ukraine | Research Site | Ivano-Frankivsk | |
| Ukraine | Research Site | Ivano-Frankivsk | |
| Ukraine | Research Site | Kharkiv Region | |
| Ukraine | Research Site | Kharkiv Region | |
| Ukraine | Research Site | Kharkiv Region | |
| Ukraine | Research Site | Kharkiv Region | |
| Ukraine | Research Site | Kharkiv Region | |
| Ukraine | Research Site | Kyiv | |
| Ukraine | Research Site | Kyiv | |
| Ukraine | Research Site | Kyiv | |
| Ukraine | Research Site | Kyiv | |
| Ukraine | Research Site | Kyiv | |
| Ukraine | Research Site | Kyiv | |
| Ukraine | Research Site | Kyiv | |
| Ukraine | Research Site | Kyiv | |
| Ukraine | Research Site | Kyiv | |
| Ukraine | Research Site | Kyiv | |
| Ukraine | Research Site | Kyiv | |
| Ukraine | Research Site | Lutsk | |
| Ukraine | Research Site | Lviv | |
| Ukraine | Research Site | Lviv | |
| Ukraine | Research Site | Mykolaiv | |
| Ukraine | Research Site | Odesa | |
| Ukraine | Research Site | Odesa | |
| Ukraine | Research Site | Odesa | |
| Ukraine | Research Site | Poltava | |
| Ukraine | Research Site | Rivne | |
| Ukraine | Research Site | Ternopil | |
| Ukraine | Research Site | Uzhhorod | |
| Ukraine | Research Site | Vinnytsia | |
| Ukraine | Research Site | Vinnytsia | |
| Ukraine | Research Site | Vinnytsia | |
| Ukraine | Research Site | Zaporizhzhia | |
| Ukraine | Research Site | Zaporizhzhia | |
| United Kingdom | Research Site | Airdrie | |
| United Kingdom | Research Site | Antrim | |
| United Kingdom | Research Site | Belfast | |
| United Kingdom | Research Site | Chesterfield | |
| United Kingdom | Research Site | Coventry | |
| United Kingdom | Research Site | Doncaster | |
| United Kingdom | Research Site | Dundee | |
| United Kingdom | Research Site | Durham | |
| United Kingdom | Research Site | Exeter | |
| United Kingdom | Research Site | Faringdon | |
| United Kingdom | Research Site | Glasgow | |
| United Kingdom | Research Site | Harrogate | |
| United Kingdom | Research Site | High Wycombe | |
| United Kingdom | Research Site | London | |
| United Kingdom | Research Site | Middlesborough | |
| United Kingdom | Research Site | Newcastle-Upon-Tyne | |
| United Kingdom | Research Site | Northampton | |
| United Kingdom | Research Site | Nottingham | |
| United Kingdom | Research Site | Paisley | |
| United Kingdom | Research Site | Peterborough | |
| United Kingdom | Research Site | Plymouth | |
| United Kingdom | Research Site | Rotherham | |
| United Kingdom | Research Site | Rothwell | |
| United Kingdom | Research Site | Sheffield | |
| United Kingdom | Research Site | Swansea | |
| United Kingdom | Research Site | Torquay | |
| United Kingdom | Research Site | York | |
| United States | Research Site | Akron | Ohio |
| United States | Research Site | Albany | New York |
| United States | Research Site | Albuquerque | New Mexico |
| United States | Research Site | Alexander City | Alabama |
| United States | Research Site | Alexandria | Louisiana |
| United States | Research Site | Alexandria | Virginia |
| United States | Research Site | Amarillo | Texas |
| United States | Research Site | Anaheim | California |
| United States | Research Site | Anderson | Indiana |
| United States | Research Site | Arlington | Texas |
| United States | Research Site | Arlington | Virginia |
| United States | Research Site | Arlington Heights | Illinois |
| United States | Research Site | Asheville | North Carolina |
| United States | Research Site | Atlanta | Georgia |
| United States | Research Site | Auburn | Maine |
| United States | Research Site | Austin | Texas |
| United States | Research Site | Austin | Texas |
| United States | Research Site | Bakersfield | California |
| United States | Research Site | Baltimore | Maryland |
| United States | Research Site | Baltimore | Maryland |
| United States | Research Site | Bangor | Maine |
| United States | Research Site | Beaumont | Texas |
| United States | Research Site | Beverly Hills | California |
| United States | Research Site | Biloxi | Mississippi |
| United States | Research Site | Binghamton | New York |
| United States | Research Site | Birmingham | Alabama |
| United States | Research Site | Bossier City | Louisiana |
| United States | Research Site | Bountiful | Utah |
| United States | Research Site | Bowie | Maryland |
| United States | Research Site | Bradenton | Florida |
| United States | Research Site | Bridgeport | Connecticut |
| United States | Research Site | Bridgewater | New Jersey |
| United States | Research Site | Bristol | Tennessee |
| United States | Research Site | Bronx | New York |
| United States | Research Site | Buffalo | New York |
| United States | Research Site | Butler | Pennsylvania |
| United States | Research Site | Calabash | North Carolina |
| United States | Research Site | Camp Hill | Pennsylvania |
| United States | Research Site | Canton | Ohio |
| United States | Research Site | Cary | North Carolina |
| United States | Research Site | Channelview | Texas |
| United States | Research Site | Chicago | Illinois |
| United States | Research Site | Chicago | Illinois |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Clayton | North Carolina |
| United States | Research Site | Clearwater | Florida |
| United States | Research Site | Cleveland | Ohio |
| United States | Research Site | Cleveland | Ohio |
| United States | Research Site | Columbia | South Carolina |
| United States | Research Site | Columbia | South Carolina |
| United States | Research Site | Columbia | South Carolina |
| United States | Research Site | Columbus | Georgia |
| United States | Research Site | Cooper City | Florida |
| United States | Research Site | Coral Springs | Florida |
| United States | Research Site | Cottonwood | Arizona |
| United States | Research Site | Covington | Louisiana |
| United States | Research Site | Crestview Hills | Kentucky |
| United States | Research Site | Crowley | Louisiana |
| * Note: There are 1242 locations in all - only the first 1000 are shown. | |||
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States, Vietnam, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine, United Kingdom,
Bhatt DL, Fox K, Harrington RA, Leiter LA, Mehta SR, Simon T, Andersson M, Himmelmann A, Ridderstråle W, Held C, Steg PG; THEMIS Steering Committee. Rationale, design and baseline characteristics of the effect of ticagrelor on health outcomes in diabetes mellitus patients Intervention study. Clin Cardiol. 2019 May;42(5):498-505. doi: 10.1002/clc.23164. Epub 2019 Apr 9. — View Citation
Bhatt DL, Steg PG, Mehta SR, Leiter LA, Simon T, Fox K, Held C, Andersson M, Himmelmann A, Ridderstråle W, Chen J, Song Y, Diaz R, Goto S, James SK, Ray KK, Parkhomenko AN, Kosiborod MN, McGuire DK, Harrington RA; THEMIS Steering Committee and Investigators. Ticagrelor in patients with diabetes and stable coronary artery disease with a history of previous percutaneous coronary intervention (THEMIS-PCI): a phase 3, placebo-controlled, randomised trial. Lancet. 2019 Sep 28;394(10204):1169-1180. doi: 10.1016/S0140-6736(19)31887-2. Epub 2019 Sep 1. — View Citation
Steg PG, Bhatt DL, Simon T, Fox K, Mehta SR, Harrington RA, Held C, Andersson M, Himmelmann A, Ridderstråle W, Leonsson-Zachrisson M, Liu Y, Opolski G, Zateyshchikov D, Ge J, Nicolau JC, Corbalán R, Cornel JH, Widimský P, Leiter LA; THEMIS Steering Committee and Investigators. Ticagrelor in Patients with Stable Coronary Disease and Diabetes. N Engl J Med. 2019 Oct 3;381(14):1309-1320. doi: 10.1056/NEJMoa1908077. Epub 2019 Sep 1. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | TIMI Major Bleeding Event (Primary Safety Objective) | Participants with TIMI major bleeding event. If no event, censoring occurs at the earliest of last endpoint assessment date, death date and 7 days following the date of last dose of study medication | From randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months. | |
| Other | TIMI Major or Minor Bleeding Event | Participants with TIMI major or minor bleeding event. If no event, censoring occurs at the earliest of last endpoint assessment date, death date and 7 days following the date of last dose of study medication | From randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months. | |
| Other | PLATO Major Bleeding Event | Participants with PLATO major bleeding event. If no event, censoring occurs at the earliest of last endpoint assessment date, death date and 7 days following the date of last dose of study medication | From randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months. | |
| Other | Permanent Discontinuation of Study Medication Due to Any Bleeding Event | Participants with permanent discontinuation of study medication due to any bleeding event. If no event, censoring occurs at the earliest of last endpoint assessment date, death date and the date of last dose of study medication | From randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months. | |
| Primary | Composite of Cardiovascular (CV) Death, MI or Stroke | Participants with Cardiovascular (CV) death, myocardial infarction (MI) or stroke. If no event, censoring occurs at the earliest of PACD, last endpoint assessment date and non-CV death date. | From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months. | |
| Secondary | CV Death | Participants with Cardiovascular (CV) death. If no event, censoring occurs at the earliest of PACD, last endpoint assessment date and non-CV death date. | From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months. | |
| Secondary | MI | Participants with myocardial infarction. If no event, censoring occurs at the earliest of primary analysis censoring date (PACD), last endpoint assessment date and death date | From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months. | |
| Secondary | Ischaemic Stroke | Participants with ischaemic stroke. If no event, censoring occurs at the earliest of PACD, last endpoint assessment date and death date. | From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months. | |
| Secondary | All-cause Death | Participants with all-cause death. If no event, censoring occurs at the earliest of PACD and last endpoint assessment date. Includes deaths based on publically available vital status data in patients who have withdrawn consent. | From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months. |
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