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

This study has been completed.
Sponsor:
Collaborators:
The Norwegian Council for Cardiovascular Diseases.
The Scientific Board, Ullevål University Hospital.
Ada and Hagbart Waages Humanitarian and Charity Foundation
Alf and Aagot Helgesens Research Foundation.
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00222261
First received: September 13, 2005
Last updated: March 22, 2011
Last verified: March 2011
  Purpose

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 Intervention Phase
Coronary Heart Disease
Angina Pectoris
Atherosclerosis
Drug: aspirin
Drug: clopidogrel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Aspirin Non-responsiveness and Clopidogrel Endpoint Trial.

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Mortality [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Myocardial infarction [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Unstable angina with ECG changes or raised levels of cardiac markers not to be classified as a myocardial infarction [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Instent restenosis and/or thrombosis detected by coronary angiography. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 1001
Study Start Date: April 2003
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00222261

Locations
Norway
Ullevaal University Hospital
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
The Norwegian Council for Cardiovascular Diseases.
The Scientific Board, Ullevål University Hospital.
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:

Additional 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
Study First Received: September 13, 2005
Last Updated: March 22, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Medicines Agency
Norway: The Data Inspectorate

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

Additional relevant MeSH terms:
Angina Pectoris
Arteriosclerosis
Atherosclerosis
Coronary Artery Disease
Coronary Disease
Heart Diseases
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Chest Pain
Pain
Signs and Symptoms
Vascular Diseases
Aspirin
Clopidogrel
Ticlopidine
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 21, 2014