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Study to Investigate Effects of Antiischemic Drug Therapy in Silent Ischemia

Swiss Interventional Study on Silent Ischemia (SWISSI 1)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00382421
Enrollment
Unknown
Registered
2006-09-29
Start date
1992-02-29
Completion date
2006-04-30
Last updated
2006-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Ischemia

Keywords

Myocardial Ischemia, Randomized Controlled Trials, Drug Therapy

Brief 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.

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.

Interventions

DRUGbisoprolol
DRUGamlodipine
DRUGmolsidomine
DRUGacetylsalicylic acid

Sponsors

Luzerner Kantonsspital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* History of cardiovascular disease

Design outcomes

Primary

MeasureTime frame
Combination of cardiac death, non-fatal myocardial infarction, unstable angina pectoris, and revascularization

Secondary

MeasureTime frame
Overall mortality
Cardiac death
Non-fatal myocardial infarction
Stable and unstable angina pectoris
Revascularization

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026