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| Sponsor: | Luzerner Kantonsspital |
|---|---|
| Information provided by: | Luzerner Kantonsspital |
| ClinicalTrials.gov Identifier: | NCT00382421 |
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) |
| Study Start Date: | February 1992 |
| Estimated Study Completion Date: | April 2006 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Switzerland | |
| Department of Cardiology, Hospital Lucerne | |
| Lucerne, Switzerland, 6000 | |
| Principal Investigator: | Paul Erne, MD | Department of Cardiology, Hospital Lucerne |
| Study Chair: | Paul Erne, MD | Department of Cardiology, Hospital Lucerne |
More Information
| 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 |
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Myocardial Ischemia Randomized Controlled Trials Drug Therapy |
|
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 |