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

This study has been completed.
Sponsor:
Collaborators:
Netherlands Heart Foundation
The Interuniversity Cardiology Institute of the Netherlands
Pfizer
Sanofi
Information provided by (Responsible Party):
Prof. Dr. F.W.A. Verheugt, Heartcenter, University Medical Center St. Radboud
ClinicalTrials.gov Identifier:
NCT00138034
First received: August 29, 2005
Last updated: April 25, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Myocardial Infarction
Procedure: Percutaneous coronary intervention (PCI)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Heartcenter, University Medical Center St. Radboud:

Primary Outcome Measures:
  • 6-month Reocclusion [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    The occurence of any one of the above mentioned outcome measures. Only the first event per patient is counted.


Enrollment: 49
Study Start Date: January 2005
Study Completion Date: February 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Percutaneous coronary intervention (PCI)
Stenting of the culprit lesion of the infarct related artery and aspirin and clopidorgel for at least 6 months
Procedure: Percutaneous coronary intervention (PCI)
PCI with bare metal stent placement of the culprit lesion the in the infarct related artery
Other Name: bare metal stent placement
Dual antiplatelet therapy
Aspirin and clopidogrel for at least 6 months
Procedure: Percutaneous coronary intervention (PCI)
PCI with bare metal stent placement of the culprit lesion the in the infarct related artery
Other Name: bare metal stent placement

Detailed Description:

Randomized controlled study of elective percutaneous coronary intervention (PCI) of an open culprit lesion after fibrinolysis for ST-elevation myocardial infarction (STEMI)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00138034

Locations
Netherlands
Radboud University Nijmegen Medical Center
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
Heartcenter, University Medical Center St. Radboud
Netherlands Heart Foundation
The Interuniversity Cardiology Institute of the Netherlands
Pfizer
Sanofi
Investigators
Principal Investigator: Freek WA Verheugt, MD PhD Radboud University Nijmegen Medical Center
  More Information

No publications provided

Responsible Party: Prof. Dr. F.W.A. Verheugt, Professor of Cardiology, Heartcenter, University Medical Center St. Radboud
ClinicalTrials.gov Identifier: NCT00138034     History of Changes
Other Study ID Numbers: APRICOT-3, 2003B257
Study First Received: August 29, 2005
Results First Received: February 20, 2012
Last Updated: April 25, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Heartcenter, University Medical Center St. Radboud:
Open infarct-related artery within 72 hours of thrombolysis

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014