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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified August 2005 by PAMI Coordinating Center.
Recruitment status was: Active, not recruiting

Sponsor:

Collaborators:

Eli Lilly and Company

Guidant Corporation

Information provided by:

PAMI Coordinating Center

ClinicalTrials.gov Identifier:

NCT00136929

First received: August 26, 2005

Last updated: December 12, 2005

Last verified: August 2005

History of Changes

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)


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	A Prospective Randomized Trial of Primary Angioplasty Versus Thrombolytic Therapy for Acute Myocardial Infarction in the Elderly "Senior PAMI"

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty Heart Attack

U.S. FDA Resources

Further study details as provided by PAMI Coordinating Center:


Estimated Enrollment:	530

Eligibility


Ages Eligible for Study:	70 Years and older (Senior)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


ClinicalTrials.gov Identifier:	NCT00136929 History of Changes
Other Study ID Numbers:	HIC 1999-225
Study First Received:	August 26, 2005
Last Updated:	December 12, 2005

Keywords provided by PAMI Coordinating Center:


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

Additional relevant MeSH terms:


Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis Myocardial Ischemia	Heart Diseases Cardiovascular Diseases Vascular Diseases Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 19, 2017

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