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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01225562
First received: July 9, 2010
Last updated: December 18, 2015
Last verified: December 2015

July 9, 2010
December 18, 2015
October 2010
December 2014   (final data collection date for primary outcome measure)
  • Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death), Myocardial Infarction (MI) or Stroke Within 3 Years From Randomization [ Time Frame: Randomization up to 47 months ] [ Designated as safety issue: No ]
    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
  • 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 [ Time Frame: First dosing up to 48 months ] [ Designated as safety issue: Yes ]
    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
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
  • Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death) Within 3 Years From Randomization [ Time Frame: Randomization up to 47 months ] [ Designated as safety issue: No ]
    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
  • Kaplan-Meier Estimate of the Percentage of Patients Who Died From Any Cause Within 3 Years From Randomization [ Time Frame: Randomization up to 47 months ] [ Designated as safety issue: No ]
    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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21379
December 2014
December 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 to 130 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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
India
 
NCT01225562
D5132C00001, 2009-017242-30
Not Provided
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Chair: Eugene Braunwald, MD TIMI Study Group
Principal Investigator: Marc Sabatine, MD, MPh TIMI Study Group
AstraZeneca
December 2015

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