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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:
The Norwegian Council for Cardiovascular Diseases.
Ada and Hagbart Waages Humanitarian and Charity Foundation
Alf and Aagot Helgesens Research Foundation.
Information provided by:
Oslo University Hospital

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 22, 2005
Last Update Posted Date March 23, 2011
Study Start Date  ICMJE April 2003
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2008)
  • Mortality [ Time Frame: 2 years ]
  • Myocardial infarction [ Time Frame: 2 years ]
  • Unstable angina with ECG changes or raised levels of cardiac markers not to be classified as a myocardial infarction [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 14, 2005)
  • Mortality
  • Myocardial infarction
  • Non-hemorrhagic stroke
  • Unstable angina with ECG changes or raised levels of cardiac markers not to be classified as a myocardial infarction
Change History Complete list of historical versions of study NCT00222261 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2008)
Instent restenosis and/or thrombosis detected by coronary angiography. [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2005)
Instent restenosis and/or thrombosis detected by coronary angiography.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aspirin Non-responsiveness and Clopidogrel Endpoint Trial.
Official Title  ICMJE Aspirin Non-responsiveness and Clopidogrel Endpoint Trial.
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Coronary Heart Disease
  • Angina Pectoris
  • Atherosclerosis
Intervention  ICMJE
  • Drug: aspirin
    Aspirin 160 mg once daily for two years
  • Drug: clopidogrel
    clopidogrel 75 mg once daily for two years
Study Arms  ICMJE
  • Active Comparator: 1, aspirin
    Aspirin 160 mg
    Intervention: Drug: aspirin
  • Active Comparator: 2, clopidogrel
    Clopidogrel 75 mg
    Intervention: Drug: clopidogrel
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 3, 2008)
1001
Original Enrollment  ICMJE
 (submitted: September 14, 2005)
1000
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00222261
Other Study ID Numbers  ICMJE ASCET
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alf-Aage R Pettersen, MD, Ullevaal University Hospital, Oslo, Norway
Study Sponsor  ICMJE Ullevaal University Hospital
Collaborators  ICMJE
  • The Norwegian Council for Cardiovascular Diseases.
  • Ada and Hagbart Waages Humanitarian and Charity Foundation
  • Alf and Aagot Helgesens Research Foundation.
Investigators  ICMJE
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
PRS Account Oslo University Hospital
Verification Date March 2011

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