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

July 9, 2010
September 26, 2014
October 2010
November 2014   (final data collection date for primary outcome measure)
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 ]
Any event after randomization from the composite of cardiovascular death, non-fatal MI, or non-fatal stroke. [ Time Frame: Within 1 year to 38 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01225562 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Cardiovascular death after randomization [ Time Frame: Within 1 year to 38 months ] [ Designated as safety issue: No ]
  • All-cause mortality after randomization [ Time Frame: Within 1 year to 38 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
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

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Myocardial Infarction
  • Cardiovascular Death
  • Atherothrombosis
  • Stroke
  • Drug: Ticagrelor 90 mg
    Oral dose twice a day
  • Drug: Ticagrelor 60 mg
    Oral dose twice a day
  • Drug: Ticagrelor Placebo
    Oral dose twice a day
  • Experimental: 1
    Oral Treatment
    Intervention: Drug: Ticagrelor 90 mg
  • Experimental: 2
    Oral Treatment
    Intervention: Drug: Ticagrelor 60 mg
  • Placebo Comparator: 3
    Oral Treatment
    Intervention: Drug: Ticagrelor Placebo
Bonaca MP, Bhatt DL, Braunwald E, Cohen M, Steg PG, Storey RF, Held P, Jensen EC, Sabatine MS. Design and rationale for the Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis in Myocardial Infarction 54 (PEGASUS-TIMI 54) trial. Am Heart J. 2014 Apr;167(4):437-444.e5. doi: 10.1016/j.ahj.2013.12.020. Epub 2014 Jan 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
21000
November 2014
November 2014   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Colombia,   United States,   Argentina,   Australia,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   China,   United Kingdom,   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
 
NCT01225562
D5132C00001, 2009-017242-30
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Chair: Eugene Braunwald, MD TIMI Study Group
Principal Investigator: Marc Sabatine, MD, MPh TIMI Study Group
AstraZeneca
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP