Study to Investigate Effects of Antiischemic Drug Therapy in Silent Ischemia

This study has been completed.
Sponsor:
Information provided by:
Luzerner Kantonsspital
ClinicalTrials.gov Identifier:
NCT00382421
First received: September 28, 2006
Last updated: October 10, 2006
Last verified: October 2006
  Purpose

There is a lack of data on the prognostic importance of silent ischemia in totally asymptomatic subjects without history of coronary artery disease (CAD), and, particularly, on a possible benefit of medical therapy in such patients. SWISSI 1 therefore recruits totally asymptomatic subjects older than 40 years of age without any history of CAD but one cardiovascular risk factor with documented silent ischemia. Participants are randomized to open antianginal drug therapy and risk factor control versus only risk factor management and followed up for ≥ 10 years.


Condition Intervention
Myocardial Ischemia
Drug: bisoprolol
Drug: amlodipine
Drug: molsidomine
Drug: acetylsalicylic acid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Swiss Interventional Study on Silent Ischemia (SWISSI 1)

Resource links provided by NLM:


Further study details as provided by Luzerner Kantonsspital:

Primary Outcome Measures:
  • Combination of cardiac death, non-fatal myocardial infarction, unstable angina pectoris, and revascularization

Secondary Outcome Measures:
  • Overall mortality
  • Cardiac death
  • Non-fatal myocardial infarction
  • Stable and unstable angina pectoris
  • Revascularization

Study Start Date: February 1992
Estimated Study Completion Date: April 2006
Detailed Description:

Although there is still controversy regarding why ischemic episodes are symptomatic in some patients and completely asymptomatic in others, it is now widely accepted that silent ischemia, like symptomatic episodes, negatively affects prognosis. Silent ischemia may occur in totally asymptomatic patients without (type I) or with a history (type II) of an ischemic cardiac event and coexists with symptomatic episodes in many patients (type III). However, there is a lack of data on the prognostic importance of silent ischemia in totally asymptomatic subjects without history of coronary artery disease (CAD), i.e. silent ischemia type I, and, particularly, on a possible benefit of medical therapy in such patients. Reasons lie in the difficulty to identify such patients and their expected low event rates implying that large patient populations and/or long follow-up periods would be necessary to come to definite conclusions. Still, to address this problem, we perform SWISSI 1 which includes totally asymptomatic subjects older than 40 years of age without any history of CAD but one cardiovascular risk factor with documented silent ischemia. They are randomized to open antianginal drug therapy and risk factor control versus only risk factor management and followed up for ≥ 10 years.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented silent myocardial ischemia type I
  • At least one cardiovascular risk factor

Exclusion Criteria:

  • History of cardiovascular disease
  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: NCT00382421

Locations
Switzerland
Department of Cardiology, Hospital Lucerne
Lucerne, Switzerland, 6000
Sponsors and Collaborators
Luzerner Kantonsspital
Investigators
Principal Investigator: Paul Erne, MD Department of Cardiology, Hospital Lucerne
Study Chair: Paul Erne, MD Department of Cardiology, Hospital Lucerne
  More Information

No publications provided by Luzerner Kantonsspital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00382421     History of Changes
Other Study ID Numbers: 1
Study First Received: September 28, 2006
Last Updated: October 10, 2006
Health Authority: Switzerland: Swissmedic

Keywords provided by Luzerner Kantonsspital:
Myocardial Ischemia
Randomized Controlled Trials
Drug Therapy

Additional relevant MeSH terms:
Myocardial Ischemia
Coronary Artery Disease
Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes
Aspirin
Molsidomine
Amlodipine
Bisoprolol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on August 18, 2014