Senior PAMI: Primary Angioplasty Versus Thrombolytic Therapy for Acute Myocardial Infarction in the Elderly

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

530 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Myocardial Infarction

Keywords

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AMI MI Acute myocardial infarction (AMI), (MI)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Thrombolytic therapy

Intervention Type DRUG

Percutaneous coronary intervention (PCI)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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)

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Felix Zijlstra, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ziekenhuis de Weezenlanden

Other Identifiers

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HIC 1999-225

Identifier Type: -

Identifier Source: org_study_id