Back to resultsComparison of Anti-Ischemic Drug Therapy and Percutaneous Transluminal Angioplasty After Myocardial Infarction
Primary Purpose
Myocardial Ischemia
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Percutaneous coronary angioplasty/intervention (PCI)
Anti-ischemic drug therapy
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Ischemia focused on measuring Myocardial Ischemia, Randomized Controlled Trials, Angioplasty, Transluminal, Percutaneous Coronary, Drug Therapy
Eligibility Criteria
Inclusion Criteria:
- Recent myocardial infarction within last 3 months
- Documented silent myocardial ischemia (type I)
Exclusion Criteria:
- Symptomatic myocardial ischemia
Sites / Locations
- Department of Cardiology, Hospital Lucerne
Outcomes
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.
Full Information
NCT ID
NCT00387231
First Posted
October 10, 2006
Last Updated
October 10, 2006
Sponsor
Luzerner Kantonsspital
1. Study Identification
Unique Protocol Identification Number
NCT00387231
Brief Title
Comparison of Anti-Ischemic Drug Therapy and Percutaneous Transluminal Angioplasty After Myocardial Infarction
Official Title
Swiss Interventional Study on Silent Ischemia (SWISSI 2)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
June 1991 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Luzerner Kantonsspital
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia
Keywords
Myocardial Ischemia, Randomized Controlled Trials, Angioplasty, Transluminal, Percutaneous Coronary, Drug Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Percutaneous coronary angioplasty/intervention (PCI)
Intervention Type
Drug
Intervention Name(s)
Anti-ischemic drug therapy
Primary Outcome Measure Information:
Title
Combination of cardiac death, non-fatal myocardial infarction, and symptom-driven revascularization
Secondary Outcome Measure Information:
Title
Overall mortality; Cardiac death; Non-fatal myocardial infarction; Symptom-driven revascularization.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Recent myocardial infarction within last 3 months
Documented silent myocardial ischemia (type I)
Exclusion Criteria:
Symptomatic myocardial ischemia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Erne, MD
Organizational Affiliation
Department of Cardiology, Hospital Lucerne
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Paul Erne, MD
Organizational Affiliation
Department of Cardiology, Hospital Lucerne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology, Hospital Lucerne
City
Lucerne
ZIP/Postal Code
6000
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
20513067
Citation
Schoenenberger AW, Jamshidi P, Kobza R, Zuber M, Stuck AE, Pfisterer M, Erne P. Progression of coronary artery disease during long-term follow-up of the Swiss Interventional Study on Silent Ischemia Type II (SWISSI II). Clin Cardiol. 2010 May;33(5):289-95. doi: 10.1002/clc.20775.
Results Reference
derived
PubMed Identifier
17488963
Citation
Erne P, Schoenenberger AW, Burckhardt D, Zuber M, Kiowski W, Buser PT, Dubach P, Resink TJ, Pfisterer M. Effects of percutaneous coronary interventions in silent ischemia after myocardial infarction: the SWISSI II randomized controlled trial. JAMA. 2007 May 9;297(18):1985-91. doi: 10.1001/jama.297.18.1985.
Results Reference
derived
Learn more about this trial
Comparison of Anti-Ischemic Drug Therapy and Percutaneous Transluminal Angioplasty After Myocardial Infarction
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