We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00387231
First Posted: October 12, 2006
Last Update Posted: October 12, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Luzerner Kantonsspital
  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
Intervention Model: Parallel Assignment
Masking: None (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00387231     History of Changes
Other Study ID Numbers: 2
First Submitted: October 10, 2006
First Posted: October 12, 2006
Last Update Posted: October 12, 2006
Last Verified: October 2006

Keywords provided by Luzerner Kantonsspital:
Myocardial Ischemia
Randomized Controlled Trials
Angioplasty, Transluminal, Percutaneous Coronary
Drug Therapy

Additional relevant MeSH terms:
Ischemia
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases