Study to Investigate Effects of Antiischemic Drug Therapy in Silent Ischemia

Myocardial Ischemia Clinical Trial

Official title:

Swiss Interventional Study on Silent Ischemia (SWISSI 1)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00382421
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• First received: September 28, 2006
• Last updated: October 10, 2006
• Start date: February 1992
• Est. completion date: April 2006

Study information

• Verified date: October 2006
• Source: Luzerner Kantonsspital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Documented silent myocardial ischemia type I

• At least one cardiovascular risk factor

Exclusion Criteria:

• History of cardiovascular disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Ischemia
• Myocardial Ischemia

Intervention

Drug:
• bisoprolol

• amlodipine

• molsidomine

• acetylsalicylic acid

Locations

Country	Name	City	State
Switzerland	Department of Cardiology, Hospital Lucerne	Lucerne

Sponsors (1)

Lead Sponsor	Collaborator
Luzerner Kantonsspital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combination of cardiac death, non-fatal myocardial infarction, unstable angina pectoris, and revascularization
Secondary	Overall mortality
Secondary	Cardiac death
Secondary	Non-fatal myocardial infarction
Secondary	Stable and unstable angina pectoris
Secondary	Revascularization