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

Primary Purpose

Myocardial Infarction

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Thrombolytic therapy

Percutaneous coronary intervention (PCI)

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring AMI, MI, Acute myocardial infarction (AMI), (MI)

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00136929

First Posted

August 26, 2005

Last Updated

December 12, 2005

Sponsor

PAMI Coordinating Center

Collaborators

Eli Lilly and Company, Guidant Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00136929

Brief Title

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

Official Title

A Prospective Randomized Trial of Primary Angioplasty Versus Thrombolytic Therapy for Acute Myocardial Infarction in the Elderly "Senior PAMI"

Study Type

Interventional

2. Study Status

Record Verification Date

August 2005

Overall Recruitment Status

Unknown status

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

PAMI Coordinating Center

Collaborators

Eli Lilly and Company, Guidant Corporation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Infarction

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

530 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Thrombolytic therapy

Intervention Type

Procedure

Intervention Name(s)

Percutaneous coronary intervention (PCI)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Felix Zijlstra, M.D.

Organizational Affiliation

Ziekenhuis de Weezenlanden

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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