Myocardial IschemiaNCT00387231
Comparison of Anti-Ischemic Drug Therapy and Percutaneous Transluminal Angioplasty After Myocardial Infarction
A study testing Percutaneous coronary angioplasty/intervention (PCI) and Anti-ischemic drug therapy in people with Myocardial Ischemia, run by Luzerner Kantonsspital at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Myocardial Ischemia
- What is being tested?
- Percutaneous coronary angioplasty/intervention (PCI) and Anti-ischemic drug therapy
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteSwitzerland
- Study dates
- Jun 1991to May 2006
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Recent myocardial infarction within last 3 months
- Documented silent myocardial ischemia (type I)
Who cannot join
- Symptomatic myocardial ischemia
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Cardiology, Hospital Lucerne
Lucerne, Canton of Lucerne, 6000
About this study
Official title: Swiss Interventional Study on Silent Ischemia (SWISSI 2)
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.
Read the 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.
- Conditions
- Myocardial Ischemia
- Being tested
- Percutaneous coronary angioplasty/intervention (PCI), Anti-ischemic drug therapy
- Keywords
- Myocardial Ischemia, Randomized Controlled Trials, Angioplasty, Transluminal, Percutaneous Coronary, Drug Therapy
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary angioplasty/intervention (PCI)Procedure or surgery
Anti-ischemic drug therapyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2006 (estimated)
- Study startJun 1991
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Luzerner Kantonsspital
- Sponsor type
- University, hospital or other
- Investigators
- Paul Erne, MD, Study chair, Department of Cardiology, Hospital LucernePaul Erne, MD, Principal investigator, Department of Cardiology, Hospital Lucerne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00387231
- Sponsor's protocol ID
- 2
- Status last verified
- Oct 2006
- First submitted
- 10 Oct 2006
- Last updated
- 12 Oct 2006
- Results posted
- No
Publications
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.
PubMed 20513067Erne 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.
PubMed 17488963