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 - Full Text View

Sponsor:	AstraZeneca
Information provided by (Responsible Party):	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01225562

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:

MedlinePlus related topics: Heart Attack Heart Diseases Vascular Diseases

Drug Information available for: Aspirin Ticagrelor

U.S. FDA Resources

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 38 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	21000
Study Start Date:	October 2010
Estimated Study Completion Date:	February 2014
Estimated Primary Completion Date:	February 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

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

Contacts

Contact: AstraZeneca Clinical Study Information

800-236-9933

Show 325 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

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:	May 17, 2012
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 Publica de Chile China: State Food and Drug Administration Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos Czech Republic: State Institute for Drug Control France: Afssaps - French Health Products Safety Agency Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy India: Drugs Controller General of India 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

Keywords provided by AstraZeneca:

Heart attack
Heart Disease
Acute coronary syndrome
ACS
Cardiovascular Disease

Additional relevant MeSH terms:

Death
Infarction
Myocardial Infarction
Stroke
Cerebral Infarction
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Cerebrovascular Disorders
Brain Diseases

Central Nervous System Diseases
Nervous System Diseases
Brain Infarction
Brain Ischemia
Ticagrelor
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 24, 2012