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

NCT ID: NCT00387231

Last Updated: 2006-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

1991-06-30

Study Completion Date

2006-05-31

Brief Summary

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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

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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

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Myocardial Ischemia

Keywords

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Myocardial Ischemia Randomized Controlled Trials Angioplasty, Transluminal, Percutaneous Coronary Drug Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Percutaneous coronary angioplasty/intervention (PCI)

Intervention Type PROCEDURE

Anti-ischemic drug therapy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Symptomatic myocardial ischemia
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Luzerner Kantonsspital

OTHER

Sponsor Role lead

Principal Investigators

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Paul Erne, MD

Role: STUDY_CHAIR

Department of Cardiology, Hospital Lucerne

Paul Erne, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Hospital Lucerne

Locations

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Department of Cardiology, Hospital Lucerne

Lucerne, Canton of Lucerne, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 20513067 (View on PubMed)

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.

Reference Type DERIVED
PMID: 17488963 (View on PubMed)

Other Identifiers

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2

Identifier Type: -

Identifier Source: org_study_id