NCT01952392

Brief Summary

Prevention of cardiovascular events by antiplatelet agents after acute coronary syndrome

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4,992

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2013

Typical duration for all trials

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

First Submitted

Initial submission to the registry

August 21, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 30, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

2.4 years

First QC Date

August 21, 2013

Last Update Submit

February 23, 2017

Conditions

Keywords

Effectiveness studyAcute coronary SyndromeReal-lifeFrance

Outcome Measures

Primary Outcomes (4)

  • Medical information

    History of coagulation and vascular disorders History of cerebrovascular accidents Cardiovascular risk factors

    At baseline visit

  • Drug exposure

    Current exposure: within 24 hours (before date of recurrent MI). Exposure to clopidogrel, ticagrelor, prasugrel, aspirin, other antiplatelet drugs.

    Current

  • Drug exposure

    Recent exposure: in the week (7 days) preceding the recurrent MI. Exposure to clopidogrel, ticagrelor, prasugrel, aspirin, other antiplatelet drugs.

    Recent

  • Drug exposure

    Past exposure: more than a week (7 days) before the recurrent MI and until the ACS index. Exposure to clopidogrel, ticagrelor, prasugrel, aspirin, other antiplatelet drugs.

    Past

Secondary Outcomes (1)

  • Other medical events of interest

    During follow-up (up to 12 months)

Study Arms (2)

Control group

Patients aged 18 years or more with an acute coronary syndrome, agreed to participate and able to answer an interview in French and/or providing the details of an alternative replier (proxy) if necessary

Case group

Patients aged 18 years or more with a history of acute coronary syndrome (i.e. a recurrent MI after myocardial history or unstable angina), agreed to participate and able to answer an interview in French and/or providing the details of an alternative replier (proxy) if necessary

Eligibility Criteria

Age18 Years - 130 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients aged 18 years or more, both genders,with an acute coronary syndrome, agreed to participate and able to respond to an interview in French and/or providing the details of an alternative replier (proxy) if necessary.

You may qualify if:

  • Patients aged 18 years or more, both genders, with an acute coronary syndrome (ACS), agreed to participate and able to respond to an interview in French and/or providing the details of an alternative replier (proxy) if necessary.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Paris, France

Location

Related Links

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

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

Study Record Dates

First Submitted

August 21, 2013

First Posted

September 30, 2013

Study Start

October 1, 2013

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

February 24, 2017

Record last verified: 2017-02

Locations