Prevention of Cardiovascular Events (eg, Death From Heart or Vascular Disease, Heart Attack, or Stroke) in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin

Stroke Clinical Trial

— PEGASUS  

Official title:

A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multinational Trial, to Assess the Prevention of Thrombotic Events With Ticagrelor Compared to Placebo on a Background of Acetyl Salicylic Acid (ASA) Therapy in Patients With History of Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01225562
• Other study ID #: D5132C00001
• Secondary ID: 2009-017242-30
• Status: Completed
• Phase: Phase 3
• First received: July 9, 2010
• Last updated: December 18, 2015
• Start date: October 2010
• Est. completion date: December 2014

Study information

• Verified date: December 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaAustralia: Department of Health and Ageing Therapeutic Goods AdministrationBelgium: Ministry of Social Affairs, Public Health and the EnvironmentBrazil: National Health Surveillance AgencyBulgaria: Bulgarian Drug AgencyCanada: Health CanadaChile: Instituto de Salud Pública de ChileChina: Food and Drug AdministrationColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosCzech Republic: State Institute for Drug ControlFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyItaly: Ethics CommitteeJapan: Ministry of Health, Labor and WelfareNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Norway: Norwegian Medicines AgencyPeru: Instituto Nacional de SaludPhilippines: Bureau of Food and DrugsPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRomania: National Medicines AgencyRussia: Pharmacological Committee, Ministry of HealthSlovakia: State Institute for Drug ControlSouth Africa: Medicines Control CouncilSouth Korea: Korea Food and Drug Administration (KFDA)Spain: Agencia Española de Medicamentos y Productos SanitariosSweden: Medical Products AgencyTurkey: Ministry of HealthUkraine: Ministry of HealthUnited States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

This study is being carried out to see if a new drug called ticagrelor given twice daily in addition to the ASA therapy decreases the frequency of cardiovascular events (e.g., death from heart disease, heart attack, or stroke).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21379
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 130 Years

Eligibility

Inclusion Criteria:

• Person who had a heart attack within 1 - 3 years ago and at least one additional risk factor: Age = 65 years old, Diabetes requiring medication, Documented history of 2nd prior MI (>1 year ago). Angiographic evidence of multivessel CAD, and / or Chronic, non-end stage renal dysfunction.

• Females of child-bearing potential must have a negative pregnancy test at enrollment

• Persons who are currently taking aspirin between 75 and 150 mg once daily

Exclusion Criteria:

• Persons who are being treated with agents inhibiting blood clotting if the agent cannot be stopped at study start

• Persons who have planned coronary, cerebrovascular, or peripheral arterial Revascularization (invasive surgery) at study start

• Persons with known bleeding disorders

• Persons who need chronic oral anticoagulant therapy or chronic low-molecular-weight heparin

• Persons with a history of ischemic stroke

• Persons with a history of intracranial bleeding at any time, a tumor or blood vessel abnormality in the brain and/or spinal cord at any time, a history of surgery involving the brain or spinal cord within the last 5 years, or a history of bleeding from the gastrointestinal tract (eg, esophagus, stomach, colon, rectum) within the last 6 months or a major surgery within the last 30 days.

• Persons considered to be at risk of bradycardic events unless already treated with a permanent pacemaker

• Persons who have had open heart surgery within the past 5 years, unless the person had a heart attack after the surgery

• Persons with known severe liver disease

• Persons with kidney failure requiring dialysis

• Persons with life expectancy < 1 year

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atherothrombosis
• Cardiovascular Death
• Infarction
• Myocardial Infarction
• Stroke

Intervention

Drug:
• Ticagrelor 90 mg
Oral dose twice a day
• Ticagrelor 60 mg
Oral dose twice a day
• Ticagrelor Placebo
Oral dose twice a day

Locations

Country	Name	City	State
Argentina	Research Site	Bahia Blanca
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Ciudad Autonoma de BA
Argentina	Research Site	Ciudad de Buenos Aires
Argentina	Research Site	Ciudadela
Argentina	Research Site	Cordoba
Argentina	Research Site	Córdoba
Argentina	Research Site	Coronel Suarez
Argentina	Research Site	Corrientes
Argentina	Research Site	Haedo
Argentina	Research Site	La Plata
Argentina	Research Site	Mar del Plata
Argentina	Research Site	Ramos Mejía
Argentina	Research Site	Rosario
Argentina	Research Site	Rosario Santa Fe
Argentina	Research Site	San Luis
Argentina	Research Site	San Miguel de Tucuman
Argentina	Research Site	San Nicolas
Argentina	Research Site	San Salvador de Jujuy
Argentina	Research Site	Santa Fe
Argentina	Research Site	Santa Fé
Argentina	Research Site	Tucuman
Argentina	Research Site	Tucumán
Argentina	Research Site	Zarate
Australia	Research Site	Adelaide
Australia	Research Site	Ashford
Australia	Research Site	Auchenflower
Australia	Research Site	Ballarat
Australia	Research Site	Bruce
Australia	Research Site	Chermside
Australia	Research Site	Clayton
Australia	Research Site	Concord
Australia	Research Site	East St Kilda
Australia	Research Site	Elizabeth Vale
Australia	Research Site	Epping
Australia	Research Site	Fremantle
Australia	Research Site	Geelong
Australia	Research Site	Gosford
Australia	Research Site	Greenslopes
Australia	Research Site	Herston
Australia	Research Site	Joondalup
Australia	Research Site	Kingswood
Australia	Research Site	Kogorah
Australia	Research Site	Launceston
Australia	Research Site	Melbourne
Australia	Research Site	Nedlands
Australia	Research Site	New Lambton Heights
Australia	Research Site	Richmond
Australia	Research Site	St Leonards
Australia	Research Site	Wollongong
Australia	Research Site	Woodville
Australia	Research Site	Woolloongabba
Belgium	Research Site	Aalst
Belgium	Research Site	Antwerpen
Belgium	Research Site	Bonheiden
Belgium	Research Site	Bouge
Belgium	Research Site	Brasschaat
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Belgium	Research Site	Brussels (Anderlecht)
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Belgium	Research Site	Charleroi
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Japan	Research Site	Toyonaka-shi
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Japan	Research Site	Wakayama-shi
Japan	Research Site	Wako-shi
Japan	Research Site	Yatsushiro-shi
Japan	Research Site	Yokohama-shi
Korea, Republic of	Research Site	Bucheon-si
Korea, Republic of	Research Site	Busan
Korea, Republic of	Research Site	Cheongju
Korea, Republic of	Research Site	Daegu
Korea, Republic of	Research Site	Daejeon
Korea, Republic of	Research Site	Gwangju
Korea, Republic of	Research Site	Jeonju
Korea, Republic of	Research Site	Seongnam-si
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Suwon-si
Korea, Republic of	Research Site	Uijeongbu
Korea, Republic of	Research Site	Wonju-si
Netherlands	Research Site	Almere
Netherlands	Research Site	Amersfoort
Netherlands	Research Site	Amsterdam
Netherlands	Research Site	Arnhem
Netherlands	Research Site	Beverwijk
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Netherlands	Research Site	Delft
Netherlands	Research Site	Den Haag
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Norway	Research Site	Bergen
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Peru	Research Site	Arequipa
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Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Colombia,  Czech Republic,  France,  Germany,  Hungary,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Norway,  Peru,  Philippines,  Poland,  Romania,  Russian Federation,  Slovakia,  South Africa,  Spain,  Sweden,  Turkey,  Ukraine,  United Kingdom, 

References & Publications (1)

Bonaca MP, Bhatt DL, Cohen M, Steg PG, Storey RF, Jensen EC, Magnani G, Bansilal S, Fish MP, Im K, Bengtsson O, Oude Ophuis T, Budaj A, Theroux P, Ruda M, Hamm C, Goto S, Spinar J, Nicolau JC, Kiss RG, Murphy SA, Wiviott SD, Held P, Braunwald E, Sabatine — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death), Myocardial Infarction (MI) or Stroke Within 3 Years From Randomization	Participants with CV death, MI or Stroke. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent, non-CV death or at the last time point of complete clinical event assessment. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who experienced CV Death, MI or stroke within 3 years from randomization	Randomization up to 47 months	No
Primary	Kaplan-Meier Estimate of the Percentage of Patients Who Experienced a TIMI Major Bleeding Within 3 Years From First Dose of Study Drug Units: Percentage of Patients	A Thrombolysis in Myocardial Infarction (TIMI) study group major bleeding is defined as any fatal bleeding (leading directly to death within 7 days), any intrcranial bleeding or any clinically overt signs of haemorrhage associated with a drop in Haemoglobin of >= 5g/dL. Events were adjudicated by a clinical events committee. Censoring ocurrs at 7 days following last dose of study drug. The Kaplan-Meier estimate reports the percentage of patients who experienced a TIMI Major bleeding within 3 years from first dose of study drug	First dosing up to 48 months	Yes
Secondary	Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death) Within 3 Years From Randomization	Participants with CV death. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent, non-CV death or at the last time point of complete clinical event assessment. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who experienced CV Death within 3 years from randomization	Randomization up to 47 months	No
Secondary	Kaplan-Meier Estimate of the Percentage of Patients Who Died From Any Cause Within 3 Years From Randomization	Participants with death from any cause. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent or the last time point the particapant was known to be alive. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who died from any cause within 3 years from randomization	Randomization up to 47 months	No

External Links

•   D5132C00001_Protocol