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APRICOT-3: Antithrombotics in the Prevention of Reocclusion In COronary Thrombolysis -3

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Percutaneous coronary intervention (PCI)
Sponsored by
Heartcenter, University Medical Center St. Radboud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Open infarct-related artery within 72 hours of thrombolysis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: TIMI-3 in infarct-related artery with a stentable lesion with 72 hours of thrombolysis for ST-elevation myocardial infarction Exclusion Criteria: Use of oral anticoagulants. Known intolerance to aspirin or clopidogrel. Bypass graft as infarct-related artery. Previously dilated infarct related artery. Significant left main stenosis. Unidentifiable culprit stenosis.

Sites / Locations

  • Radboud University Nijmegen Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Percutaneous coronary intervention (PCI)

Dual antiplatelet therapy

Arm Description

Stenting of the culprit lesion of the infarct related artery and aspirin and clopidorgel for at least 6 months

Aspirin and clopidogrel for at least 6 months

Outcomes

Primary Outcome Measures

6-month Reocclusion
Less than TIMI (Thrombolysis In Myocardial Infarction) -3 flow of the infarct related coronary artery assessed at follow-up angiography

Secondary Outcome Measures

Composite of Death, Reinfarction, Stroke and Revascularization at the Time of Follow-up Angiography
The occurence of any one of the above mentioned outcome measures. Only the first event per patient is counted.

Full Information

First Posted
August 29, 2005
Last Updated
April 25, 2012
Sponsor
Heartcenter, University Medical Center St. Radboud
Collaborators
Netherlands Heart Foundation, The Interuniversity Cardiology Institute of the Netherlands, Pfizer, Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00138034
Brief Title
APRICOT-3: Antithrombotics in the Prevention of Reocclusion In COronary Thrombolysis -3
Official Title
A Multicenter Randomized Trial in the Prevention of Reocclusion Following Successful Thrombolysis for Suspected Acute Myocardial Infarction: An Invasive Versus a Conservative Strategy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heartcenter, University Medical Center St. Radboud
Collaborators
Netherlands Heart Foundation, The Interuniversity Cardiology Institute of the Netherlands, Pfizer, Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Reocclusion of the infarct artery is observed in about 30% of patients within three months after successful thrombolysis for acute myocardial infarction (MI). Reocclusion is associated with an increased risk of death, reinfarction and the need for revascularization. Even in the absence of clinical reinfarction, reocclusion results in impaired left ventricular (LV) recovery, leaving patients at increased risk of developing heart failure in the long-term. Prevention of reocclusion is therefore warranted. In previous trials, severity of the infarct related stenosis was the only independent predictor of reocclusion. With a lack of clinical predictors of reocclusion, many cardiologists therefore empirically favor routine revascularization after successful thrombolysis. The APRICOT-3 will be the first randomized trial in the current era of improved angioplasty techniques to study the question of whether a routine invasive strategy after successful thrombolysis can reduce the incidence of reocclusion and subsequently improve clinical outcome and LV-function. After successful thrombolysis, patients will be randomized to either a routine invasive strategy or an ischemia-guided strategy. The investigators expect to demonstrate a lower reocclusion rate at the 6-month follow-up angiography (primary endpoint) and fewer associated events (death, reinfarction, revascularization, admissions for heart failure) in the routine invasive arm. In search of non-invasive parameters predictive of reocclusion, laboratory analysis of several coagulation and inflammatory markers will be performed. Finally, pooled analysis of all 3 APRICOT trials will focus on the identification of clinical predictors of reocclusion that can easily be obtained by history and physical examination.
Detailed Description
Randomized controlled study of elective percutaneous coronary intervention (PCI) of an open culprit lesion after fibrinolysis for ST-elevation myocardial infarction (STEMI)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Open infarct-related artery within 72 hours of thrombolysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Percutaneous coronary intervention (PCI)
Arm Type
Active Comparator
Arm Description
Stenting of the culprit lesion of the infarct related artery and aspirin and clopidorgel for at least 6 months
Arm Title
Dual antiplatelet therapy
Arm Type
Other
Arm Description
Aspirin and clopidogrel for at least 6 months
Intervention Type
Procedure
Intervention Name(s)
Percutaneous coronary intervention (PCI)
Other Intervention Name(s)
bare metal stent placement
Intervention Description
PCI with bare metal stent placement of the culprit lesion the in the infarct related artery
Primary Outcome Measure Information:
Title
6-month Reocclusion
Description
Less than TIMI (Thrombolysis In Myocardial Infarction) -3 flow of the infarct related coronary artery assessed at follow-up angiography
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Composite of Death, Reinfarction, Stroke and Revascularization at the Time of Follow-up Angiography
Description
The occurence of any one of the above mentioned outcome measures. Only the first event per patient is counted.
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: TIMI-3 in infarct-related artery with a stentable lesion with 72 hours of thrombolysis for ST-elevation myocardial infarction Exclusion Criteria: Use of oral anticoagulants. Known intolerance to aspirin or clopidogrel. Bypass graft as infarct-related artery. Previously dilated infarct related artery. Significant left main stenosis. Unidentifiable culprit stenosis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Freek WA Verheugt, MD PhD
Organizational Affiliation
Radboud University Nijmegen Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud University Nijmegen Medical Center
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500 HB
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

APRICOT-3: Antithrombotics in the Prevention of Reocclusion In COronary Thrombolysis -3

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