NCT00222261

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,001

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2003

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

March 23, 2011

Status Verified

March 1, 2011

Enrollment Period

7.3 years

First QC Date

September 13, 2005

Last Update Submit

March 22, 2011

Conditions

Coronary Heart DiseaseAngina PectorisAtherosclerosis

Keywords

antiplatelet therapyaspirin non-respondersaspirin resistanceclopidogrelcoronary heart diseasestable angina pectoris

Outcome Measures

Primary Outcomes (3)

  • Mortality

    2 years

  • Myocardial infarction

    2 years

  • Unstable angina with ECG changes or raised levels of cardiac markers not to be classified as a myocardial infarction

    2 years

Secondary Outcomes (1)

  • Instent restenosis and/or thrombosis detected by coronary angiography.

    2 years

Study Arms (2)

1, aspirin

ACTIVE COMPARATOR

Aspirin 160 mg

Drug: aspirin

2, clopidogrel

ACTIVE COMPARATOR

Clopidogrel 75 mg

Drug: clopidogrel

Interventions

aspirinDRUG

Aspirin 160 mg once daily for two years

1, aspirin
clopidogrelDRUG

clopidogrel 75 mg once daily for two years

2, clopidogrel

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ullevaal University Hospital

Oslo, 0407, Norway

Location

Related Publications (22)

  • Antithrombotic Trialists' Collaboration. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ. 2002 Jan 12;324(7329):71-86. doi: 10.1136/bmj.324.7329.71.

    PMID: 11786451BACKGROUND

  • Buchanan MR, Brister SJ. Individual variation in the effects of ASA on platelet function: implications for the use of ASA clinically. Can J Cardiol. 1995 Mar;11(3):221-7.

    PMID: 7889440BACKGROUND

  • Grotemeyer KH. Effects of acetylsalicylic acid in stroke patients. Evidence of nonresponders in a subpopulation of treated patients. Thromb Res. 1991 Sep 15;63(6):587-93. doi: 10.1016/0049-3848(91)90085-b.

    PMID: 1780803BACKGROUND

  • Gum PA, Kottke-Marchant K, Poggio ED, Gurm H, Welsh PA, Brooks L, Sapp SK, Topol EJ. Profile and prevalence of aspirin resistance in patients with cardiovascular disease. Am J Cardiol. 2001 Aug 1;88(3):230-5. doi: 10.1016/s0002-9149(01)01631-9.

    PMID: 11472699BACKGROUND

  • Helgason CM, Bolin KM, Hoff JA, Winkler SR, Mangat A, Tortorice KL, Brace LD. Development of aspirin resistance in persons with previous ischemic stroke. Stroke. 1994 Dec;25(12):2331-6. doi: 10.1161/01.str.25.12.2331.

    PMID: 7974569BACKGROUND

  • Hurlen M, Seljeflot I, Arnesen H. The effect of different antithrombotic regimens on platelet aggregation after myocardial infarction. Scand Cardiovasc J. 1998;32(4):233-7. doi: 10.1080/14017439850140021.

    PMID: 9802142BACKGROUND

  • De Gaetano G, Cerletti C. Aspirin resistance: a revival of platelet aggregation tests? J Thromb Haemost. 2003 Sep;1(9):2048-50. doi: 10.1046/j.1538-7836.2003.00354.x. No abstract available.

    PMID: 12941050BACKGROUND

  • Patrono C. Aspirin resistance: definition, mechanisms and clinical read-outs. J Thromb Haemost. 2003 Aug;1(8):1710-3. doi: 10.1046/j.1538-7836.2003.00284.x. No abstract available.

    PMID: 12911581BACKGROUND

  • Grotemeyer KH, Scharafinski HW, Husstedt IW. Two-year follow-up of aspirin responder and aspirin non responder. A pilot-study including 180 post-stroke patients. Thromb Res. 1993 Sep 1;71(5):397-403. doi: 10.1016/0049-3848(93)90164-j.

    PMID: 8236166BACKGROUND

  • Buchanan MR, Schwartz L, Bourassa M, Brister SJ, Peniston CM; BRAT Investigators. Results of the BRAT study--a pilot study investigating the possible significance of ASA nonresponsiveness on the benefits and risks of ASA on thrombosis in patients undergoing coronary artery bypass surgery. Can J Cardiol. 2000 Nov;16(11):1385-90.

    PMID: 11109035BACKGROUND

  • Gum PA, Kottke-Marchant K, Welsh PA, White J, Topol EJ. A prospective, blinded determination of the natural history of aspirin resistance among stable patients with cardiovascular disease. J Am Coll Cardiol. 2003 Mar 19;41(6):961-5. doi: 10.1016/s0735-1097(02)03014-0.

    PMID: 12651041BACKGROUND

  • CAPRIE Steering Committee. A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). CAPRIE Steering Committee. Lancet. 1996 Nov 16;348(9038):1329-39. doi: 10.1016/s0140-6736(96)09457-3.

    PMID: 8918275BACKGROUND

  • Hurlen M, Abdelnoor M, Smith P, Erikssen J, Arnesen H. Warfarin, aspirin, or both after myocardial infarction. N Engl J Med. 2002 Sep 26;347(13):969-74. doi: 10.1056/NEJMoa020496.

    PMID: 12324552BACKGROUND

  • Andersen K, Hurlen M, Arnesen H, Seljeflot I. Aspirin non-responsiveness as measured by PFA-100 in patients with coronary artery disease. Thromb Res. 2002 Oct 1;108(1):37-42. doi: 10.1016/s0049-3848(02)00405-x.

    PMID: 12586130BACKGROUND

  • Pettersen AA, Seljeflot I, Abdelnoor M, Arnesen H. Unstable angina, stroke, myocardial infarction and death in aspirin non-responders. A prospective, randomized trial. The ASCET (ASpirin non-responsiveness and Clopidogrel Endpoint Trial) design. Scand Cardiovasc J. 2004 Dec;38(6):353-6. doi: 10.1080/14017430410024324.

    PMID: 15804802BACKGROUND

  • Opstad TB, Nordeng J, Pettersen AR, Akra S, Bratseth V, Zaidi H, Helseth R, Solheim S, Seljeflot I. The NLRP3 Genetic Variant (rs10754555) Reduces the Risk of Adverse Outcome in Middle-Aged Patients with Chronic Coronary Syndrome. J Immunol Res. 2022 Dec 20;2022:2366695. doi: 10.1155/2022/2366695. eCollection 2022.

    PMID: 36582742DERIVED

  • Warlo EMK, Bratseth V, Pettersen AR, Holme PA, Arnesen H, Seljeflot I, Opstad TB. Genetic Variation in ADAMTS13 is Related to VWF Levels, Atrial Fibrillation and Cerebral Ischemic Events. Clin Appl Thromb Hemost. 2022 Jan-Dec;28:10760296221141893. doi: 10.1177/10760296221141893.

    PMID: 36474435DERIVED

  • Warlo EMK, Pettersen AR, Arnesen H, Seljeflot I. vWF/ADAMTS13 is associated with on-aspirin residual platelet reactivity and clinical outcome in patients with stable coronary artery disease. Thromb J. 2017 Nov 22;15:28. doi: 10.1186/s12959-017-0151-3. eCollection 2017.

    PMID: 29200971DERIVED

  • Pettersen AA, Seljeflot I, Abdelnoor M, Arnesen H. High On-Aspirin Platelet Reactivity and Clinical Outcome in Patients With Stable Coronary Artery Disease: Results From ASCET (Aspirin Nonresponsiveness and Clopidogrel Endpoint Trial). J Am Heart Assoc. 2012 Jun;1(3):e000703. doi: 10.1161/JAHA.112.000703. Epub 2012 Jun 22.

    PMID: 23130135DERIVED

  • Bratseth V, Pettersen AA, Opstad TB, Arnesen H, Seljeflot I. Markers of hypercoagulability in CAD patients. Effects of single aspirin and clopidogrel treatment. Thromb J. 2012 Aug 10;10(1):12. doi: 10.1186/1477-9560-10-12.

    PMID: 22883224DERIVED

  • Opstad TB, Pettersen AA, Arnesen H, Seljeflot I. Circulating levels of IL-18 are significantly influenced by the IL-18 +183 A/G polymorphism in coronary artery disease patients with diabetes type 2 and the metabolic syndrome: an observational study. Cardiovasc Diabetol. 2011 Dec 5;10:110. doi: 10.1186/1475-2840-10-110.

    PMID: 22141572DERIVED

  • Pettersen AA, Arnesen H, Opstad TB, Seljeflot I. The influence of CYP 2C19*2 polymorphism on platelet function testing during single antiplatelet treatment with clopidogrel. Thromb J. 2011 Mar 22;9:4. doi: 10.1186/1477-9560-9-4.

    PMID: 21426546DERIVED

MeSH Terms

Conditions

Coronary DiseaseAngina PectorisAtherosclerosisAngina, Stable

Interventions

AspirinClopidogrel

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsArteriosclerosisArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTiclopidineThienopyridinesThiophenesSulfur CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Alf-Aage R. Pettersen, M.D.

    Dept. of Cardiology, Ullevaal University Hospital, Oslo

    PRINCIPAL INVESTIGATOR

  • Harald Arnesen, M.D. Ph.D.

    Center for Clinical Cardiovascular Research, Ullevaal University Hospital, Oslo

    STUDY CHAIR

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

April 1, 2003

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

March 23, 2011

Record last verified: 2011-03

Locations

NO(1)