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Sponsored by: |
Kantonsspital Luzern |
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Information provided by: | Kantonsspital Luzern |
ClinicalTrials.gov Identifier: | NCT00382421 |
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 |
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Myocardial Ischemia |
Drug: bisoprolol Drug: amlodipine Drug: molsidomine Drug: acetylsalicylic acid |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
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.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study ID Numbers: | 1 |
Study First Received: | September 28, 2006 |
Last Updated: | October 10, 2006 |
ClinicalTrials.gov Identifier: | NCT00382421 History of Changes |
Health Authority: | Switzerland: Swissmedic |
Myocardial Ischemia Randomized Controlled Trials Drug Therapy |
Anti-Inflammatory Agents Neurotransmitter Agents Vasodilator Agents Adrenergic Agents Myocardial Ischemia Calcium Channel Blockers Fibrinolytic Agents Nitric Oxide Donors Fibrin Modulating Agents Aspirin Adrenergic beta-Antagonists Anti-Inflammatory Agents, Non-Steroidal Analgesics Molsidomine Heart Diseases |
Cyclooxygenase Inhibitors Vascular Diseases Ischemia Cardiovascular Agents Antihypertensive Agents Amlodipine Nitric Oxide Calcium, Dietary Bisoprolol Analgesics, Non-Narcotic Adrenergic Antagonists Platelet Aggregation Inhibitors Peripheral Nervous System Agents Antirheumatic Agents |
Anti-Inflammatory Agents Neurotransmitter Agents Vasodilator Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Myocardial Ischemia Physiological Effects of Drugs Hematologic Agents Calcium Channel Blockers Fibrinolytic Agents Nitric Oxide Donors Membrane Transport Modulators Fibrin Modulating Agents Pathologic Processes Aspirin |
Sensory System Agents Therapeutic Uses Adrenergic beta-Antagonists Anti-Inflammatory Agents, Non-Steroidal Cardiovascular Diseases Analgesics Molsidomine Sympatholytics Heart Diseases Cyclooxygenase Inhibitors Vascular Diseases Enzyme Inhibitors Ischemia Cardiovascular Agents Antihypertensive Agents |