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NCT00387231 Clinical Trial

Comparison of Anti-Ischemic Drug Therapy and Percutaneous Transluminal Angioplasty After Myocardial Infarction

Myocardial Ischemia Clinical Trial

Official title:
Swiss Interventional Study on Silent Ischemia (SWISSI 2)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00387231
Other study ID # 2
Secondary ID
Status Completed
Phase N/A
First received October 10, 2006
Last updated October 10, 2006
Start date June 1991
Est. completion date May 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

Silent ischemia has been shown to negatively affect prognosis in patients after myocardial infarction. However, long-term outcome data in totally asymptomatic patients is missing and it is unknown whether angioplasty in addition to secondary preventive measures is superior to antiischemic drug therapy in these patients. Therefore, the SWISSI 2 study was started 15 years ago with the aim of comparing the effects of angioplasty with medical therapy on long-term outcome in patients with recent myocardial infarction and silent ischemia.

Description:

Silent ischemia has been shown to negatively affect prognosis in patients after myocardial infarction (MI). Despite these consistent findings, there are almost no prospective data unequivocally documenting a benefit of antiischemic therapy on prognosis in patients with silent ischemia. There is some indirect evidence of a better outcome after repeat angioplasty for silent restenosis. In patients with a recent MI, the Asymptomatic Cardiac Ischemia Pilot study documented a short-term benefit of antiischemic drug therapy and angioplasty in patients with silent and symptomatic ischemic episodes. However, long-term outcome data in totally asymptomatic patients is missing and it is unknown whether angioplasty in addition to secondary preventive measures is superior to antiischemic drug therapy in these patients. Therefore, the (SWISSI 2) study was started 15 years ago with the aim of comparing the effects of angioplasty with medical therapy, each combined with secondary preventive advice, aspirin and statin therapy, on long-term outcome in patients with recent MI and an exercise test without symptoms but silent ischemia verified by stress imaging.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date May 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Recent myocardial infarction within last 3 months

- Documented silent myocardial ischemia (type I)

Exclusion Criteria:

- Symptomatic myocardial ischemia

Study Design

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

Related Conditions & MeSH terms

Intervention

Procedure:
• Percutaneous coronary angioplasty/intervention (PCI)

Drug:
• Anti-ischemic drug therapy

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, and symptom-driven revascularization
Secondary Overall mortality; Cardiac death; Non-fatal myocardial infarction; Symptom-driven revascularization.
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