NCT01390974

Brief Summary

To demonstrate that a strategy of fast genetic testing performed in outpatient clinic allows to select adequately one of the 2 antiplatelet treatments approved in the same indication (ACS with PCI - prasugrel 10mg MD or clopidogrel 75mg MD). Patients will reach similar levels of platelet inhibition with the 2 different thienopyridines suggesting optimal risk/benefit ratio in most patients with individualized therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2011

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

July 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

February 10, 2014

Status Verified

February 1, 2014

Enrollment Period

1.3 years

First QC Date

July 7, 2011

Last Update Submit

February 7, 2014

Conditions

Acute Coronary Syndrome

Keywords

ACSPCIthienopyridinesprasugrel therapyclopidogrel therapy

Outcome Measures

Primary Outcomes (1)

  • proportion of patients who are within the optimal prespecified window of P2Y12 inhibition

    the proportion of rapid metabolizers treated with a 75mg clopidogrel MD within the optimal range of P2Y12 inhibition at 30 days, (defined as a threshold of 220 AU·min up to 350 AU·min of ADP-induced platelet aggregation measured by the Multiple Electrode platelet Aggregometry - Multiplate analyzer, Dynabyte, Munich, Germany or a % inhibition between 30% up to 80% using the VerifyNowTMP2Y12 platform),

    At one month

Secondary Outcomes (1)

  • proportion of patients who are within the optimal prespecified window of P2Y12 inhibition

    at 45 days

Study Arms (1)

Patients treated for ACS

ACS patients who recently underwent stent PCI, who are stable and eligible for prasugrel or clopidogrel therapy.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ACS patients who recently underwent stent PCI, who are stable and eligible for prasugrel or clopidogrel therapy.

You may qualify if:

  • \- ACS patients who underwent Percutaneous coronary intervention

You may not qualify if:

  • Anemia \<10g/dL
  • Indication for VKA
  • Recent bleeding or planned surgery
  • Thrombopenia \<80 000/µl

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ACTION-Institut de Cardiologie-Groupe Hospitalier Pitié-Salpêtrière (APHP) Université Pierre et Marie Curie (UPMC)

Paris, 75013, France

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Jean Philippe COLLET, PUPH

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2011

First Posted

July 11, 2011

Study Start

July 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

February 10, 2014

Record last verified: 2014-02

Locations

FR(1)