NCT00382421

Brief Summary

There is a lack of data on the prognostic importance of silent ischemia in totally asymptomatic subjects without history of coronary artery disease (CAD), and, particularly, on a possible benefit of medical therapy in such patients. SWISSI 1 therefore recruits totally asymptomatic subjects older than 40 years of age without any history of CAD but one cardiovascular risk factor with documented silent ischemia. Participants are randomized to open antianginal drug therapy and risk factor control versus only risk factor management and followed up for ≥ 10 years.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Feb 1992

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1992

Completed
14.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 29, 2006

Completed
Last Updated

October 12, 2006

Status Verified

October 1, 2006

First QC Date

September 28, 2006

Last Update Submit

October 10, 2006

Conditions

Myocardial Ischemia

Keywords

Myocardial IschemiaRandomized Controlled TrialsDrug Therapy

Outcome Measures

Primary Outcomes (1)

  • Combination of cardiac death, non-fatal myocardial infarction, unstable angina pectoris, and revascularization

Secondary Outcomes (5)

  • Overall mortality

  • Cardiac death

  • Non-fatal myocardial infarction

  • Stable and unstable angina pectoris

  • Revascularization

Interventions

bisoprololDRUG
amlodipineDRUG
molsidomineDRUG
acetylsalicylic acidDRUG

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documented silent myocardial ischemia type I
  • At least one cardiovascular risk factor

You may not qualify if:

  • History of cardiovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Hospital Lucerne

Lucerne, Canton of Lucerne, 6000, Switzerland

Location

Related Publications (1)

  • Schoenenberger AW, Jamshidi P, Zuber M, Stuck AE, Pfisterer M, Erne P. Coronary artery disease is common in asymptomatic patients with signs of myocardial ischemia. Eur J Intern Med. 2009 Oct;20(6):607-10. doi: 10.1016/j.ejim.2009.04.001. Epub 2009 May 8.

    PMID: 19782922DERIVED

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

BisoprololAmlodipineMolsidomineAspirin

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesDihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsSydnonesOxadiazolesOxazolesAzolesMorpholinesOxazinesSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Paul Erne, MD

    Department of Cardiology, Hospital Lucerne

    PRINCIPAL INVESTIGATOR

  • Paul Erne, MD

    Department of Cardiology, Hospital Lucerne

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 28, 2006

First Posted

September 29, 2006

Study Start

February 1, 1992

Study Completion

April 1, 2006

Last Updated

October 12, 2006

Record last verified: 2006-10

Locations

CH(1)