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

This study has been completed.
Sponsor:
Information provided by:
Luzerner Kantonsspital
ClinicalTrials.gov Identifier:
NCT00387231
First received: October 10, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted
  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)

Resource links provided by NLM:


Further study details as provided by Luzerner Kantonsspital:

Primary Outcome Measures:
  • Combination of cardiac death, non-fatal myocardial infarction, and symptom-driven revascularization

Secondary Outcome Measures:
  • Overall mortality; Cardiac death; Non-fatal myocardial infarction; Symptom-driven revascularization.

Study Start Date: June 1991
Estimated Study Completion Date: May 2006
Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Symptomatic myocardial ischemia
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00387231

Locations
Switzerland
Department of Cardiology, Hospital Lucerne
Lucerne, Switzerland, 6000
Sponsors and Collaborators
Luzerner Kantonsspital
Investigators
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:
Coronary Artery Disease
Ischemia
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014