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Study to Investigate Effects of Antiischemic Drug Therapy in Silent Ischemia
This study has been completed.
First Received: September 28, 2006   Last Updated: October 10, 2006   History of Changes
Sponsored by: Kantonsspital Luzern
Information provided by: Kantonsspital Luzern
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: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Swiss Interventional Study on Silent Ischemia (SWISSI 1)

Resource links provided by NLM:


Further study details as provided by Kantonsspital Luzern:

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00382421

Locations
Switzerland
Department of Cardiology, Hospital Lucerne
Lucerne, Switzerland, 6000
Sponsors and Collaborators
Kantonsspital Luzern
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

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

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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 03, 2009