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 (PEGASUS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01225562
First received: July 9, 2010
Last updated: September 26, 2014
Last verified: September 2014
  Purpose

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).


Condition Intervention Phase
Myocardial Infarction
Cardiovascular Death
Atherothrombosis
Stroke
Drug: Ticagrelor 90 mg
Drug: Ticagrelor 60 mg
Drug: Ticagrelor Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Any event after randomization from the composite of cardiovascular death, non-fatal MI, or non-fatal stroke. [ Time Frame: Within 1 year to 44 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiovascular death after randomization [ Time Frame: Within 1 year to 44 months ] [ Designated as safety issue: No ]
  • All-cause mortality after randomization [ Time Frame: Within 1 year to 44 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 21000
Study Start Date: October 2010
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Oral Treatment
Drug: Ticagrelor 90 mg
Oral dose twice a day
Experimental: 2
Oral Treatment
Drug: Ticagrelor 60 mg
Oral dose twice a day
Placebo Comparator: 3
Oral Treatment
Drug: Ticagrelor Placebo
Oral dose twice a day

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01225562

  Show 848 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: Eugene Braunwald, MD TIMI Study Group
Principal Investigator: Marc Sabatine, MD, MPh TIMI Study Group
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01225562     History of Changes
Other Study ID Numbers: D5132C00001, 2009-017242-30
Study First Received: July 9, 2010
Last Updated: September 26, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Ministry of Social Affairs, Public Health and the Environment
Brazil: National Health Surveillance Agency
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
China: Food and Drug Administration
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Italy: Ethics Committee
Japan: Ministry of Health, Labor and Welfare
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Norway: Norwegian Medicines Agency
Peru: Instituto Nacional de Salud
Philippines: Bureau of Food and Drugs
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Russia: Pharmacological Committee, Ministry of Health
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Turkey: Ministry of Health
Ukraine: Ministry of Health
United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
Heart attack
Heart Disease
Acute coronary syndrome
ACS
Cardiovascular Disease

Additional relevant MeSH terms:
Myocardial Infarction
Stroke
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Heart Diseases
Nervous System Diseases
Vascular Diseases
Death
Infarction
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Ticagrelor
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists

ClinicalTrials.gov processed this record on October 20, 2014