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Aspirin Non-responsiveness and Clopidogrel Endpoint Trial. (ASCET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00222261
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : March 23, 2011
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
In the ASCET study, 1000 patients with documented coronary heart disease will be randomized to either continued treatment with aspirin 160 mg/d or change to clopidogrel 75mg/d. Clinical endpoints will be recorded for at least 2 years and related to the initial aspirin response, assessed by the PFA-100® method, to investigate whether aspirin non-responders have higher composite event rate than responders or whether Clopidogrel treatment in patients non-responsive to aspirin will reduce their risk of future clinical events. The clinical events are the composite of unstable angina, myocardial infarction, stroke or death.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Angina Pectoris Atherosclerosis Drug: aspirin Drug: clopidogrel Phase 4

Detailed Description:

Background: Aspirin is widely used as an antiplatelet drug in patients with coronary heart disease. Despite documented clinical benefit, many patients on aspirin still experience severe cardiovascular events. Several laboratory reports have shown lack of platelet inhibition in 5-40% of aspirin-treated patients, and the term aspirin resistance has been introduced. The clinical relevance of these laboratory findings is, however, still unknown. New antiplatelet drugs have been developed, and the adenosin diphosphate (ADP) receptor inhibitor clopidogrel has at least the same efficacy as aspirin with an acceptable safety profile. Laboratory methods for determination of platelet reactivity and treatment efficacy have been complicated and time consuming. New methodologies, like the PFA-100® system, have made such analyses more suitable for clinical use.

Design: In the ASCET study, 1000 patients with documented coronary heart disease will be randomized to either continued treatment with aspirin 160 mg/d or change to clopidogrel 75mg/d after initial determination of their platelet reactivity while on aspirin treatment. Clinical endpoints will be recorded for at least 2 years and related to the initial aspirin response.

Scand Cardiovasc J. 2004 Dec;38(6):353-6.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1001 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aspirin Non-responsiveness and Clopidogrel Endpoint Trial.
Study Start Date : April 2003
Primary Completion Date : July 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1, aspirin
Aspirin 160 mg
Drug: aspirin
Aspirin 160 mg once daily for two years
Active Comparator: 2, clopidogrel
Clopidogrel 75 mg
Drug: clopidogrel
clopidogrel 75 mg once daily for two years


Outcome Measures

Primary Outcome Measures :
  1. Mortality [ Time Frame: 2 years ]
  2. Myocardial infarction [ Time Frame: 2 years ]
  3. Unstable angina with ECG changes or raised levels of cardiac markers not to be classified as a myocardial infarction [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Instent restenosis and/or thrombosis detected by coronary angiography. [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stable, symptomatic coronary heart disease, verified by coronary angiography, being treated with angioplasty/stent implantation (PCI) or not.

Exclusion Criteria:

  • Indication for warfarin treatment.
  • Indication for or contraindication to the study drugs.
  • Pregnancy or breast-feeding.
  • Malignancy that may interfere with life expectancy.
  • Psychiatric disease, mental retardation, dementia, drug abuse, alcoholism or conditions that can severely reduce compliance.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00222261


Locations
Norway
Ullevaal University Hospital
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
The Norwegian Council for Cardiovascular Diseases.
Ada and Hagbart Waages Humanitarian and Charity Foundation
Alf and Aagot Helgesens Research Foundation.
Investigators
Principal Investigator: Alf-Aage R. Pettersen, M.D. Dept. of Cardiology, Ullevaal University Hospital, Oslo
Study Chair: Harald Arnesen, M.D. Ph.D. Center for Clinical Cardiovascular Research, Ullevaal University Hospital, Oslo
Study Director: Ingebjorg Seljeflot, Ph.D. Center for Clinical Cardiovascular Research, Ullevaal University Hospital, Oslo
Study Director: Michael Abdelnoor, Ph.D. Center for Clinical Cardiovascular Research, Ullevaal University Hospital, Oslo
Study Director: Arne Westheim, M.D. Ph.D Dept. of Cardiology, Ullevaal University Hospital, Oslo
More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alf-Aage R Pettersen, MD, Ullevaal University Hospital, Oslo, Norway
ClinicalTrials.gov Identifier: NCT00222261     History of Changes
Other Study ID Numbers: ASCET
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: March 23, 2011
Last Verified: March 2011

Keywords provided by Oslo University Hospital:
antiplatelet therapy
aspirin non-responders
aspirin resistance
clopidogrel
coronary heart disease
stable angina pectoris

Additional relevant MeSH terms:
Heart Diseases
Atherosclerosis
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Angina Pectoris
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Aspirin
Ticlopidine
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors