NCT00136929

Brief Summary

This is a prospective, randomized, multi-center, international trial comparing two reperfusion strategies in elderly (age \>= 70 years) patients with acute myocardial infarction: primary percutaneous coronary intervention (PCI) versus intravenous thrombolytic therapy. Clinical endpoints will be collected in the hospital, at 1 month, 6 months, and 1 year post-randomization. The primary endpoint is 30 day death or disabling stroke. The study null hypothesis is that there will be no significant difference in death or disabling stroke at 30 days post-randomization between patients treated with PCI versus thrombolytics.

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
530

participants targeted

Target at P75+ for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2005

Completed
Last Updated

December 13, 2005

Status Verified

August 1, 2005

First QC Date

August 26, 2005

Last Update Submit

December 12, 2005

Conditions

Myocardial Infarction

Keywords

AMIMIAcute myocardial infarction (AMI), (MI)

Interventions

Thrombolytic therapyDRUG
Percutaneous coronary intervention (PCI)PROCEDURE

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age \>= 70
  • Clinical symptoms \> 30 minutes
  • Symptom onset \<= 12 hours
  • ST segment elevation \>= 1 mm in 2 or more leads

You may not qualify if:

  • Prior thrombolytics
  • Cardiogenic shock
  • Cerebrovascular accident (CVA)
  • Prolonged cardiopulmonary resuscitation (CPR)
  • Blood pressure (BP) \> 180/100 mm Hg
  • Active bleeding
  • International Normalized Ratio (INR) \> 1.4
  • Acetylsalicylic acid \[aspirin\] (ASA) or heparin allergy
  • History of neutropenia, thrombocytopenia, hepatic dysfunction, or renal insufficiency
  • Peripheral vascular disease (PVD)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Thrombolytic TherapyPercutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Felix Zijlstra, M.D.

    Ziekenhuis de Weezenlanden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 26, 2005

First Posted

August 29, 2005

Last Updated

December 13, 2005

Record last verified: 2005-08