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NCT Number: NCT00387231

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

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.

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Key information

Conditions

Myocardial Ischemia Cardiovascular Diseases Heart Diseases Vascular Diseases

Age range

0 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

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Recent myocardial infarction within last 3 months
  • Documented silent myocardial ischemia (type I)

Exclusion criteria

  • Symptomatic myocardial ischemia

Treatment and study plan

Percutaneous coronary angioplasty/intervention (PCI)

Procedure

Anti-ischemic drug therapy

Drug

Primary outcomes

  1. Combination of cardiac death, non-fatal myocardial infarction, and symptom-driven revascularization

Secondary outcomes

  1. Overall mortality; Cardiac death; Non-fatal myocardial infarction; Symptom-driven revascularization.

Sponsors and collaborators

Lead sponsor

Luzerner Kantonsspital

Other

Registry information

Official study title

Swiss Interventional Study on Silent Ischemia (SWISSI 2)

Important dates

Study start
1991
Study completion
2006
First posted
Oct 12, 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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