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

This study is ongoing, but not recruiting participants.

First Received: August 26, 2005 Last Updated: December 12, 2005 History of Changes

Sponsors and Collaborators:	PAMI Coordinating Center Eli Lilly and Company Guidant Corporation
Information provided by:	PAMI Coordinating Center
ClinicalTrials.gov Identifier:	NCT00136929

Purpose

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.

Condition	Intervention
Myocardial Infarction	Drug: Thrombolytic therapy Procedure: Percutaneous coronary intervention (PCI)

MedlinePlus related topics: Angioplasty Heart Attack

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety Study
Official Title:	A Prospective Randomized Trial of Primary Angioplasty Versus Thrombolytic Therapy for Acute Myocardial Infarction in the Elderly "Senior PAMI"

Further study details as provided by PAMI Coordinating Center:

Estimated Enrollment:

530

Eligibility

Ages Eligible for Study:	70 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136929

Sponsors and Collaborators

PAMI Coordinating Center

Eli Lilly and Company

Guidant Corporation

Investigators

Principal Investigator:

Felix Zijlstra, M.D.

Ziekenhuis de Weezenlanden

More Information

No publications provided

Study ID Numbers:	HIC 1999-225
Study First Received:	August 26, 2005
Last Updated:	December 12, 2005
ClinicalTrials.gov Identifier:	NCT00136929 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by PAMI Coordinating Center:

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

Study placed in the following topic categories:

Fibrin Modulating Agents
Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Fibrinolytic Agents
Cardiovascular Agents
Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Heart Diseases
Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Hematologic Agents
Vascular Diseases
Fibrinolytic Agents
Cardiovascular Agents
Ischemia

Pharmacologic Actions
Necrosis
Fibrin Modulating Agents
Pathologic Processes
Therapeutic Uses
Cardiovascular Diseases
Infarction
Myocardial Infarction

ClinicalTrials.gov processed this record on May 07, 2009