NCT00822536

Brief Summary

To compare treatment with aspirin alone versus the combined antiplatelet treatment aspirin and clopidogrel after 12 months of combined antiplatelet treatment following drug-eluting stent (DES) implantation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,798

participants targeted

Target at P75+ for phase_4 coronary-artery-disease

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_4 coronary-artery-disease

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

January 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2009

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

October 17, 2014

Status Verified

October 1, 2014

Enrollment Period

5.7 years

First QC Date

January 13, 2009

Last Update Submit

October 16, 2014

Conditions

Coronary Artery DiseaseStent ThrombosisMyocardial Ischemia

Keywords

Drug-eluting stentClopidogrelStent thrombosisMyocardial infarction

Outcome Measures

Primary Outcomes (1)

  • Composite criteria : death, non fatal myocardial infarction, non fatal stroke and severe bleeding

    At each visit (every 6 months) with Follow-up of 3 years

Secondary Outcomes (7)

  • Death

    At each visit (every 6 months) with Follow-up of 3 years

  • Non fatal myocardial infarction

    At each visit (every 6 months) with Follow-up of 3 years

  • Non fatal stroke

    At each visit (every 6 months) with Follow-up of 3 years

  • Severe bleeding

    At each visit (every 6 months) with Follow-up of 3 years

  • Stent thrombosis (ARC définition)

    At each visit (every 6 months) with Follow-up of 3 years

  • +2 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

Bi therapy : aspirin/ clopidogrel

Drug: Aspirin and Clopidogrel

2

ACTIVE COMPARATOR

Monotherapy: aspirin

Drug: Aspirin

Interventions

Aspirin and ClopidogrelDRUG

Aspirin \<= 325 mg/j Clopidogrel = 75 mg /j

Also known as: Aspirin: acid acetylsalycilic, Clopidogrel: plavix
1
AspirinDRUG

Aspirin : \<= 325 mg/j

Also known as: Aspirin: acid acetylsalycilic
2

Eligibility Criteria

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

You may qualify if:

  • Patients on aspirin and clopidogrel therapy at 12 months after DES implantation
  • Informed, written consent by the patient

You may not qualify if:

  • DES in left main coronary artery
  • Oral anticoagulation therapy with coumadin derivatives
  • Active bleeding; bleeding diathesis; history intracranial bleeding
  • Known allergy or intolerance to the study medications: aspirin and clopidogrel
  • Pregnancy (present, suspected or planned) or positive pregnancy test (In women with childbearing potential a negative pregnancy test is mandatory)
  • Patient's inability to fully comply with the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital la Pitié Salpêtrière Institut de Cardiologie

Paris, 75010, France

Location

Related Publications (2)

  • Helft G, Steg PG, Le Feuvre C, Georges JL, Carrie D, Dreyfus X, Furber A, Leclercq F, Eltchaninoff H, Falquier JF, Henry P, Cattan S, Sebagh L, Michel PL, Tuambilangana A, Hammoudi N, Boccara F, Cayla G, Douard H, Diallo A, Berman E, Komajda M, Metzger JP, Vicaut E; OPTImal DUAL Antiplatelet Therapy Trial Investigators. Stopping or continuing clopidogrel 12 months after drug-eluting stent placement: the OPTIDUAL randomized trial. Eur Heart J. 2016 Jan 21;37(4):365-74. doi: 10.1093/eurheartj/ehv481. Epub 2015 Sep 12.

    PMID: 26364288DERIVED

  • Helft G, Le Feuvre C, Georges JL, Carrie D, Leclercq F, Eltchaninoff H, Furber A, Prunier F, Sebagh L, Cattan S, Cayla G, Vicaut E, Metzger JP. Efficacy and safety of 12 versus 48 months of dual antiplatelet therapy after implantation of a drug-eluting stent: the OPTImal DUAL antiplatelet therapy (OPTIDUAL) trial: study protocol for a randomized controlled trial. Trials. 2013 Feb 21;14:56. doi: 10.1186/1745-6215-14-56.

    PMID: 23433461DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial IschemiaMyocardial Infarction

Interventions

AspirinClopidogrel

Condition Hierarchy (Ancestors)

Coronary DiseaseHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Gérard HELFT, MD,PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 13, 2009

First Posted

January 14, 2009

Study Start

January 1, 2009

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

October 17, 2014

Record last verified: 2014-10

Locations

FR(1)