NCT01231035

Brief Summary

The main objective of the project is to assess the long-term prognostic impact of residual platelet reactivity after optimal antiplatelet therapy in a large cohort of patients with acute coronary syndrome undergoing invasive strategy. Follow-up length will be at least 24 months. The primary end-point of the study will be a composite of death, myocardial infarction, urgent target vessel revascularization, stent thrombosis or stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,789

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2008

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

Study Start

First participant enrolled

September 1, 2008

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

July 25, 2011

Status Verified

July 1, 2011

Enrollment Period

2.5 years

First QC Date

October 29, 2010

Last Update Submit

July 22, 2011

Conditions

Acute Cardiac SyndromeStent ThrombosisPlatelet FunctionAntiplatelet Therapy

Keywords

acute cardiac syndromestent thrombosisplatelet functionantiplatelet therapy

Outcome Measures

Primary Outcomes (1)

  • long-term prognostic impact of residual platelet reactivity

    to assess the long-term prognostic impact of residual platelet reactivity after optimal antiplatelet therapy in a large cohort of patients with acute coronary syndrome undergoing invasive strategy.

    24 months

Eligibility Criteria

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

patients with acute coronary syndrome who received invasive treatment and for whom platelet reactivity after clopidogrel treatment will be prospectively assessed.

You may qualify if:

  • acute coronary syndrome
  • invasive treatment

You may not qualify if:

  • in-hospital death that was not due to stent thrombosis,
  • anticipated poor compliance to dual antipletelet treatment for at least 6 months,
  • premature discontinuation of clopidogrel therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Careggi Hospital, Department of Heart and Vessels

Florence, 50134, Italy

Location

Related Publications (1)

  • Parodi G, Marcucci R, Valenti R, Gori AM, Migliorini A, Giusti B, Buonamici P, Gensini GF, Abbate R, Antoniucci D. High residual platelet reactivity after clopidogrel loading and long-term cardiovascular events among patients with acute coronary syndromes undergoing PCI. JAMA. 2011 Sep 21;306(11):1215-23. doi: 10.1001/jama.2011.1332.

    PMID: 21934054BACKGROUND

Study Officials

  • David Antoniucci, MD

    Careggi Hospital, Division of Invasive Cardiology

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 29, 2010

First Posted

November 1, 2010

Study Start

September 1, 2008

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

July 25, 2011

Record last verified: 2011-07

Locations

IT(1)