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Timi 54 Cardiac Banner

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)

Sponsor: AstraZeneca, November 2010


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). 
ConditionInterventionPhase
Myocardial Infarction
Cardiovascular Death
Atherothrombosis
Stroke
Drug: Ticagrelor 90 mg
Drug: Ticagrelor 60 mg
Drug: Ticagrelor Placebo
Phase III
Study Type:
Study Design






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

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
Estimated Enrollment:

Study Start Date:

Estimated Study Completion Date:

Estimated Primary Completion Date:
21000

October 2010

February 2014

February 2014 (Final data collection date for primary outcome measure)

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Eligibility


Ages Eligible for Study:
Genders Eligible for Study:
Accepts Healthy Volunteers:
50 Years and older
Both
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
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Contacts and Locations

Physicians:
Ameer Kabour, MD
Raza Hashmi, MD
Tarif Kanaan, MD
Mohammad Alkhateeb, MD

Coordinators:
Michelle Hickam, RN, BSN
Brenda Hoagland, RN, CCRC
Julie Neidhardt, RN, BSN

Please contact us at 419-251-4919 for further information about this study.
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