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

NCT00138034 | Completed Phase 4 Results

• 2 other identifiers: APRICOT-32003B257
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction

Keywords

Open infarct-related artery within 72 hours of thrombolysis

Outcome Measures

Primary Outcomes (1)

• 6-month Reocclusion

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

  6 months

Secondary Outcomes (1)

• Composite of Death, Reinfarction, Stroke and Revascularization at the Time of Follow-up Angiography

  6 months

Study Arms (2)

Percutaneous coronary intervention (PCI)

ACTIVE COMPARATOR

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

Procedure: Percutaneous coronary intervention (PCI)

Dual antiplatelet therapy

OTHER

Aspirin and clopidogrel for at least 6 months

Procedure: Percutaneous coronary intervention (PCI)

Interventions

Percutaneous coronary intervention (PCI) PROCEDURE

PCI with bare metal stent placement of the culprit lesion the in the infarct related artery

Also known as: bare metal stent placement

Dual antiplatelet therapy; Percutaneous coronary intervention (PCI)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• TIMI-3 in infarct-related artery with a stentable lesion with 72 hours of thrombolysis for ST-elevation myocardial infarction

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heartcenter, University Medical Center St. Radboud: lead
• Netherlands Heart Foundation: collaborator
• The Interuniversity Cardiology Institute of the Netherlands: collaborator
• Pfizer: collaborator
• Sanofi: collaborator

Study Sites (1)

Radboud University Nijmegen Medical Center

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Results Point of Contact

• Title: Professor Doctor F.W.A. Verheugt
• Organization: Radboud University Medical Center Nijmegen

f.verheugt@cardio.umcn.nl

+31(0)24-3614533

Study Officials

• Freek WA Verheugt, MD PhD

  Radboud University Nijmegen Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology

Study Record Dates

• First Submitted: August 29, 2005
• First Posted: August 30, 2005
• Study Start: January 1, 2005
• Primary Completion: January 1, 2010
• Study Completion: February 1, 2010
• Last Updated: April 30, 2012
• Results First Posted: April 19, 2012

Record last verified: 2012-04

Locations

NL (1)