Peripheral Artery Disease Clinical Trial
— EUCLIDOfficial title:
A Randomized, Double-blind, Parallel Group, Multicentre Phase IIIb Study to Compare Ticagrelor With Clopidogrel Treatment on the Risk of Cardiovascular Death, Myocardial Infarction and Ischemic Stroke in Patients With Established Peripheral Artery Disease (EUCLID Examining Use of tiCagreLor In paD)
| Verified date | September 2017 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to compare the effects of ticagrelor and clopidogrel in patients with Peripheral Artery Disease.
| Status | Completed |
| Enrollment | 13885 |
| Est. completion date | September 26, 2016 |
| Est. primary completion date | September 26, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 50 Years to 130 Years |
| Eligibility |
Inclusion Criteria: - Male and Female patients 50 years old or older Symptomatic peripheral artery disease Exclusion Criteria: - Patients needing dual anti-platlet drug treatment before start of study Planned revascularisation or amputation - Patients with known bleeding disorders - Patients with a history of intracranial bleed - Patients considered to be at risk of bradycardic events unless already treated with a permanent pacemaker |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Research Site | Buenos aires | |
| Argentina | Research Site | Buenos Aires | |
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| United States | Research Site | Haddon Heights | New Jersey |
| United States | Research Site | Haverhill | Massachusetts |
| United States | Research Site | Hawthorne | New York |
| United States | Research Site | Hershey | Pennsylvania |
| United States | Research Site | High Point | North Carolina |
| United States | Research Site | Hillsboro | Oregon |
| United States | Research Site | Hinsdale | Illinois |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Hudson | Florida |
| United States | Research Site | Hurst | Texas |
| United States | Research Site | Idaho Falls | Idaho |
| United States | Research Site | Indianapolis | Indiana |
| United States | Research Site | Indianapolis | Indiana |
| United States | Research Site | Iowa City | Iowa |
| United States | Research Site | Jackson | Mississippi |
| United States | Research Site | Jackson | Tennessee |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Johnson City | New York |
| United States | Research Site | Jonesboro | Arkansas |
| United States | Research Site | Kalamazoo | Michigan |
| United States | Research Site | Kalispell | Montana |
| United States | Research Site | Kansas City | Missouri |
| United States | Research Site | Kettering | Ohio |
| United States | Research Site | Killeen | Texas |
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| United States | Research Site | La Jolla | California |
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| United States | Research Site | Lansing | Michigan |
| United States | Research Site | Largo | Florida |
| United States | Research Site | Las Vegas | Nevada |
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| United States | Research Site | Lenoir | North Carolina |
| United States | Research Site | Lincoln | Nebraska |
| United States | Research Site | Lincoln | Nebraska |
| United States | Research Site | Linden | New Jersey |
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| United States | Research Site | Liverpool | New York |
| United States | Research Site | Long Beach | California |
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| United States | Research Site | Loveland | Colorado |
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| United States | Research Site | Lynchburg | Virginia |
| United States | Research Site | Macon | Georgia |
| United States | Research Site | Madison | Wisconsin |
| United States | Research Site | Manassas | Virginia |
| United States | Research Site | Manitowoc | Wisconsin |
| United States | Research Site | Martinez | Georgia |
| United States | Research Site | McAllen | Texas |
| United States | Research Site | McAllen | Texas |
| United States | Research Site | McKinney | Texas |
| United States | Research Site | Memphis | Tennessee |
| United States | Research Site | Merrillville | Indiana |
| United States | Research Site | Mesa | Arizona |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Midlothian | Virginia |
| United States | Research Site | Milwaukee | Wisconsin |
| United States | Research Site | Minneapolis | Minnesota |
| United States | Research Site | Minneapolis | Minnesota |
| United States | Research Site | Minot | North Dakota |
| United States | Research Site | Mission Viejo | California |
| United States | Research Site | Mobile | Alabama |
| United States | Research Site | Mobile | Alabama |
| United States | Research Site | Mobile | Alabama |
| United States | Research Site | Mooresville | North Carolina |
| United States | Research Site | Moreno Valley | California |
| United States | Research Site | Mount Clemens | Michigan |
| United States | Research Site | Muncie | Indiana |
| United States | Research Site | Munster | Indiana |
| United States | Research Site | Muskegon | Michigan |
| United States | Research Site | Nashville | Tennessee |
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| United States | Research Site | New Brunswick | New Jersey |
| United States | Research Site | New York | New York |
| United States | Research Site | New York | New York |
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| United States | Research Site | Newark | New Jersey |
| United States | Research Site | Newark | New Jersey |
| United States | Research Site | Newark | Delaware |
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| United States | Research Site | North Las Vegas | Nevada |
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| United States | Research Site | Ocala | Florida |
| United States | Research Site | Ocean City | New Jersey |
| United States | Research Site | Oceanside | California |
| United States | Research Site | Odessa | Texas |
| United States | Research Site | Ogden | Utah |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Orange | California |
| United States | Research Site | Orange Park | Florida |
| United States | Research Site | Owensboro | Kentucky |
| United States | Research Site | Palm Harbor | Florida |
| United States | Research Site | Palo Alto | California |
| United States | Research Site | Pawtucket | Rhode Island |
| United States | Research Site | Pensacola | Florida |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | Phoenix | Arizona |
| United States | Research Site | Phoenix | Arizona |
| United States | Research Site | Plantation | Florida |
| United States | Research Site | Poughkeepsie | New York |
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| United States | Research Site | Raleigh | North Carolina |
| United States | Research Site | Raleigh | North Carolina |
| United States | Research Site | Rapid City | South Dakota |
| United States | Research Site | Rock Island | Illinois |
| United States | Research Site | Rockford | Illinois |
| United States | Research Site | Rocky Mount | North Carolina |
| United States | Research Site | Round Rock | Texas |
| United States | Research Site | Sacramento | California |
| United States | Research Site | Sacramento | California |
| United States | Research Site | Safety Harbor | Florida |
| United States | Research Site | Saint Cloud | Minnesota |
| United States | Research Site | Saint Louis | Missouri |
| United States | Research Site | Saint Louis | Missouri |
| United States | Research Site | Saint Louis | Missouri |
| United States | Research Site | Saint Louis | Missouri |
| United States | Research Site | Saint Petersburg | Florida |
| United States | Research Site | Saint Petersburg | Florida |
| United States | Research Site | Salt Lake City | Utah |
| United States | Research Site | San Diego | California |
| United States | Research Site | San Diego | California |
| United States | Research Site | San Francisco | California |
| United States | Research Site | Sarasota | Florida |
| United States | Research Site | Saratoga Springs | New York |
| United States | Research Site | Savannah | Georgia |
| United States | Research Site | Sayre | Pennsylvania |
| United States | Research Site | Scottsdale | Arizona |
| United States | Research Site | Sellersville | Pennsylvania |
| United States | Research Site | Sewell | New Jersey |
| United States | Research Site | Shreveport | Louisiana |
| United States | Research Site | Shreveport | Louisiana |
| United States | Research Site | South Charleston | West Virginia |
| United States | Research Site | Spokane | Washington |
| United States | Research Site | Spokane | Washington |
| United States | Research Site | Springfield | Ohio |
| United States | Research Site | Stamford | Connecticut |
| United States | Research Site | Statesville | North Carolina |
| United States | Research Site | Stockton | California |
| United States | Research Site | Stuart | Florida |
| United States | Research Site | Summit | New Jersey |
| United States | Research Site | Tacoma | Washington |
| United States | Research Site | Tallahassee | Florida |
| United States | Research Site | Tampa | Florida |
| United States | Research Site | Tampa | Florida |
| United States | Research Site | The Bronx | New York |
| United States | Research Site | The Bronx | New York |
| United States | Research Site | Toledo | Ohio |
| United States | Research Site | Torrance | California |
| United States | Research Site | Torrance | California |
| United States | Research Site | Trinity | Florida |
| United States | Research Site | Troy | New York |
| United States | Research Site | Trumbull | Connecticut |
| United States | Research Site | Tucker | Georgia |
| United States | Research Site | Tupelo | Mississippi |
| United States | Research Site | Tyler | Texas |
| United States | Research Site | Tyler | Texas |
| United States | Research Site | Valparaiso | Indiana |
| United States | Research Site | Vero Beach | Florida |
| United States | Research Site | Victoria | Texas |
| United States | Research Site | Voorhees | New Jersey |
| United States | Research Site | Washington, D.C. | District of Columbia |
| United States | Research Site | Wausau | Wisconsin |
| United States | Research Site | Webster | Texas |
| United States | Research Site | Wellington | Florida |
| United States | Research Site | West Des Moines | Iowa |
| United States | Research Site | West Orange | New Jersey |
| United States | Research Site | West Palm Beach | Florida |
| United States | Research Site | Williamsville | New York |
| United States | Research Site | Wilmington | North Carolina |
| United States | Research Site | Wilmington | Delaware |
| United States | Research Site | Winchester | Virginia |
| United States | Research Site | Winston-Salem | North Carolina |
| United States | Research Site | Worcester | Massachusetts |
| United States | Research Site | Wormleysburg | Pennsylvania |
| United States | Research Site | Wyomissing | Pennsylvania |
| United States | Research Site | Yonkers | New York |
| United States | Research Site | York | Pennsylvania |
| United States | Research Site | Youngstown | Ohio |
| United States | Research Site | Zanesville | Ohio |
| Vietnam | Research Site | Hanoi | |
| Vietnam | Research Site | Hcmc | |
| Vietnam | Research Site | Ho Chi Minh | |
| Vietnam | Research Site | Ho Chi Minh | |
| Vietnam | Research Site | Hochiminh |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States, Vietnam, Argentina, Brazil, Bulgaria, Canada, Chile, China, Czechia, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Philippines, Poland, Romania, Russian Federation, Slovakia, Spain, Sweden, Thailand, Turkey, Ukraine, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Net Clinical Benefit (Composite of CV Death/MI/Ischemic Stroke/Fatal Bleeding/Intracranial Bleeding) | Participants with CV death, MI, ischemic stroke, fatal bleeding or intracranial bleeding. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date) | From randomization to PACD, an average of 2.5 years | |
| Other | Net Clinical Benefit (Composite of All-cause Mortality/MI/Ischemic Stroke/Fatal Bleeding/Intracranial Bleeding) | Participants with all-cause death, MI, ischemic stroke, fatal bleeding or intracranial bleeding. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date) | From randomization to PACD, an average of 2.5 years | |
| Other | Net Clinical Benefit (Composite of All-cause Mortality/MI/Ischemic Stroke/ALI/Major Amputation/Fatal Bleeding/Intracranial Bleeding) | Participants with all-cause death, MI, ischemic stroke, ALI, major amputation, fatal bleeding or intracranial bleeding. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date) | From randomization to PACD, an average of 2.5 years | |
| Other | Net Clinical Benefit (Composite of All-cause Mortality/MI/Ischemic Stroke/ALI/Major Amputation/TIMI Major Bleeding) | Participants with all-cause death, MI, ischemic stroke, ALI, major amputation or Thrombolysis in Myocardial Infarction (TIMI) major bleeding. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date) | From randomization to PACD, an average of 2.5 years | |
| Other | Non-CV Death | Participants with non-CV death. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, CV death) | From randomization to PACD, an average of 2.5 years | |
| Other | Changes in Fontaine Stage | Progression of the clinical/symptomatic status of the limb by changes in Fontaine stage. Stage I - Asymptomatic Stage IIa - Intermittent claudication after more than 200 meters of pain free walking Stage IIb - Intermittent claudication after less than 200 meters of walking Stage III - Rest pain Stage IV - Ischemic ulcers or gangrene |
From randomization to PACD, an average of 2.5 years | |
| Other | Changes in Rutherford Classification | Progression of the clinical/symptomatic status of the limb by changes in Rutherford classification. Category 0 - Asymptomatic Category 1 - Mild claudication Category 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters. Category 3 - Severe claudication Category 4 - Rest pain Category 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Category 6 - Severe ischemic ulcers or frank gangrene |
From randomization to PACD, an average of 2.5 years | |
| Other | Change in ABI/TBI From Baseline | Change in ankle brachial index (ABI) / toe brachial index (TBI). Ankle brachial index (ABI) is the ratio of blood pressures from the ankle and arm and is used for diagnosing peripheral arterial occlusive disease (PAOD): Normal: 1 to 1.29 Borderline: 0.91 to 0.99 Mild PAOD: 0.71 to 0.90 Medium severe PAOD: 0.41 to 0.7 Severe PAOD: <0.4 Toe brachial index (TBI) is the ratio between the toe pressure and the higher brachial pressure, used for diagnosing PAOD when the ABI cannot be used: Normal: >0.7 Mild: 0.5-0.7 Moderate: 0.35-0.5 Moderate-Severe: <0.35 and toe pressure 40 mmHg Severe: <0.35 and toe pressure < 30 mmHg |
From randomization to PACD, an average of 2.5 years | |
| Other | Any Amputation Caused by PAD | Participants with any amputation caused by peripheral arterial disease (PAD). If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date) | From randomization to PACD, an average of 2.5 years | |
| Other | Major Amputation Caused by PAD | Participants with major amputation caused by PAD. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date) | From randomization to PACD, an average of 2.5 years | |
| Other | CV-related Hospitalization | Participants with hospitalization associated with CV death, hospitalization due to MI, ischemic stroke, lower extremity revascularization, major amputation due to PAD, transient ischemic attack (TIA), coronary revascularization or unstable angina. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date) | From randomization to PACD, an average of 2.5 years | |
| Other | TIMI Major Bleeding Events | Participants with TIMI major bleeding event. If no event, censoring occurs at the minimum of (last endpoint assessment date, death date, 7 days after last dose of study drug) | From the date of first dose and up to and including 7 days following the date of last dose of study drug | |
| Other | TIMI Major or Minor Bleeding Events | Participants with TIMI major or minor bleeding event. If no event, censoring occurs at the minimum of (last endpoint assessment date, death date, 7 days after last dose of study drug) | From the date of first dose and up to and including 7 days following the date of last dose of study drug | |
| Other | PLATO Major Bleeding Events | Participants with PLATO major bleeding event. If no event, censoring occurs at the minimum of (last endpoint assessment date, death date, 7 days after last dose of study drug) | From the date of first dose and up to and including 7 days following the date of last dose of study drug | |
| Other | Premature Permanent Discontinuation of Study Drug Due to Any Bleeding Event | Participants with a permanent discontinuation of study drug due to any bleeding event. If no event, censoring occurs at the minimum of (last endpoint assessment date, death date, 7 days after last dose of study drug) | From the date of first dose and up to and including 7 days following the date of last dose of study drug | |
| Primary | Composite of Cardiovascular (CV) Death/MI/Ischemic Stroke | Participants with CV death, myocardial infarction (MI) or ischemic stroke. If no event, censoring occurs at the minimum of (primary analysis censoring date (PACD), last endpoint assessment date, non-CV death date) | From randomization to PACD, an average of 2.5 years | |
| Secondary | Composite of CV Death, MI, Ischemic Stroke, and ALI | Participants with CV death, MI, ischemic stroke or acute limb ischemia (ALI). If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date) | From randomization to PACD, an average of 2.5 years | |
| Secondary | CV Death | Participants with CV death. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date) | From randomization to PACD, an average of 2.5 years | |
| Secondary | MI | Participants with MI. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date) | From randomization to PACD, an average of 2.5 years | |
| Secondary | All-cause Mortality | Participants with all-cause death. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date) | From randomization to PACD, an average of 2.5 years | |
| Secondary | Composite of CV Death, MI, and All-cause Stroke (Ischemic or Hemorrhagic) | Participants with CV death, MI or all-cause stroke. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date) | From randomization to PACD, an average of 2.5 years | |
| Secondary | ALI | Participants with ALI. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date) | From randomization to PACD, an average of 2.5 years | |
| Secondary | Lower Extremity Revascularization | Participants with lower extremity revascularization (LER). If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date) | From randomization to PACD, an average of 2.5 years | |
| Secondary | Any Revascularisation (Coronary, Peripheral [Limb, Mesenteric, Renal, Carotid and Other]) | Participants with any revascularization. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date) | From randomization to PACD, an average of 2.5 years |
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