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Completed

NCT Number: NCT00382421

Study to Investigate Effects of Antiischemic Drug Therapy in Silent Ischemia

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cardiology, Hospital Lucerne

Lucerne, Canton of Lucerne, 6000, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • History of cardiovascular disease

Treatment and study plan

Bisoprolol

Drug

Amlodipine

Drug

molsidomine

Drug

acetylsalicylic acid

Drug

Primary outcomes

  1. Combination of cardiac death, non-fatal myocardial infarction, unstable angina pectoris, and revascularization

Secondary outcomes

  1. Overall mortality

  2. Cardiac death

  3. Non-fatal myocardial infarction

  4. Stable and unstable angina pectoris

  5. Revascularization

Sponsors and collaborators

Lead sponsor

Luzerner Kantonsspital

Other

Registry information

Official study title

Swiss Interventional Study on Silent Ischemia (SWISSI 1)

Important dates

Study start
1992
Study completion
2006
First posted
Sep 29, 2006
Registry last updated
Oct 12, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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