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Left Ventricular Function After Acute Myocardial Infarction (AMI). Treatment With Angiotensin 2-Receptor Blockade (GLOBAL-Study)

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ClinicalTrials.gov Identifier: NCT00125645
Recruitment Status : Completed
First Posted : August 1, 2005
Last Update Posted : May 8, 2018
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Kenneth Egstrup, University of Southern Denmark

Brief Summary:
The purpose of this study is to compare changes in global left ventricular (LV) function after 3 months of treatment with irbesartan compared with usual care in patients with acute myocardial infarction, a wall motion score >1.3 (EF>0.40) and signs of diastolic dysfunction. The hypothesis is that an angiotensin 2-receptor inhibitor will improve global left ventricular function.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Drug: Irbesartan Oral Tablet Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Comparison with EF
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Global Left Ventricular Function After Acute Myocardial Infarction. Treatment With the Angiotensin 2-Receptor Blocker Irbesartan
Actual Study Start Date : March 1, 2005
Actual Primary Completion Date : September 1, 2011
Actual Study Completion Date : September 1, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Irbesartan
Tablet Irbesartan 150 mg once daily
Drug: Irbesartan Oral Tablet



Primary Outcome Measures :
  1. Left ventricular function [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented AMI; MPI > 0.55
  • Randomized within 7 days of AMI
  • Written informed consent

Exclusion Criteria:

  • Age < 18 years
  • Any contraindications to angiotensin 2-receptor blockade
  • In patients with WMSI > 1.3 treatment with ACE-inhibitor or angiotensin 2-receptor blockers
  • In patients with WMSI <= 1.3 no initiated or planned treatment with an ACE-inhibitor. Treatment with an ACE-inhibitor must be started within 7 days
  • Pregnancy or women of childbearing potential who are not using an effective method of contraception
  • Other comorbid conditions that could influence the study
  • Currently receiving an experimental study drug

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00125645


Locations
Denmark
Kardiologisk Klinik, Centralsygehuset Esbjerg/Varde
Esbjerg, Denmark, 6700
Sponsors and Collaborators
University of Southern Denmark
Bristol-Myers Squibb
Investigators
Study Chair: Kenneth Egstrup, Asst. Professor Department of Medical Research, SHF Svendborg

Responsible Party: Kenneth Egstrup, Professor, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT00125645     History of Changes
Other Study ID Numbers: VF 20040053
2612
First Posted: August 1, 2005    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: April 2007

Keywords provided by Kenneth Egstrup, University of Southern Denmark:
AMI
Left ventricular function
Myocardial performance index
Acute myocardial infarction (AMI)

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Irbesartan
Angiotensin II
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents