Comparison of Anti-Ischemic Drug Therapy and Percutaneous Transluminal Angioplasty After Myocardial Infarction
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Myocardial Ischemia |
Procedure: Percutaneous coronary angioplasty/intervention (PCI) Drug: Anti-ischemic drug therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Swiss Interventional Study on Silent Ischemia (SWISSI 2) |
- Combination of cardiac death, non-fatal myocardial infarction, and symptom-driven revascularization
- Overall mortality; Cardiac death; Non-fatal myocardial infarction; Symptom-driven revascularization.
| Study Start Date: | June 1991 |
| Estimated Study Completion Date: | May 2006 |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Recent myocardial infarction within last 3 months
- Documented silent myocardial ischemia (type I)
Exclusion Criteria:
- Symptomatic myocardial ischemia
Contacts and Locations| Switzerland | |
| Department of Cardiology, Hospital Lucerne | |
| Lucerne, Switzerland, 6000 | |
| Study Chair: | Paul Erne, MD | Department of Cardiology, Hospital Lucerne |
| Principal Investigator: | Paul Erne, MD | Department of Cardiology, Hospital Lucerne |
More Information
No publications provided by Luzerner Kantonsspital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00387231 History of Changes |
| Other Study ID Numbers: | 2 |
| Study First Received: | October 10, 2006 |
| Last Updated: | October 10, 2006 |
| Health Authority: | Switzerland: Swissmedic |
Keywords provided by Luzerner Kantonsspital:
|
Myocardial Ischemia Randomized Controlled Trials Angioplasty, Transluminal, Percutaneous Coronary Drug Therapy |
Additional relevant MeSH terms:
|
Myocardial Ischemia Coronary Artery Disease Ischemia Myocardial Infarction Heart Diseases Cardiovascular Diseases |
Vascular Diseases Coronary Disease Arteriosclerosis Arterial Occlusive Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013