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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00192868
Other study ID # DEDICATION
Secondary ID
Status Active, not recruiting
Phase N/A
First received September 12, 2005
Last updated September 22, 2009
Start date May 2005
Est. completion date November 2011

Study information

Verified date September 2009
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: National Board of Health
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the clinical, echocardiographic and angiographic outcome of distal protection in the infarct related coronary artery and implantation of drug eluting versus bare metal stents in patients with ST-elevation myocardial infarctions treated acutely with percutaneous coronary intervention.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 600
Est. completion date November 2011
Est. primary completion date November 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Acute onset typical chest pain of < 12 hours' duration

- ST-elevation of > 4 mm (1mm = 0.1 mV) in contiguous leads of the electrocardiogram

- High grade stenosis or occlusion of a native major coronary artery that can be crossed with a soft or intermediate tip guidewire

- Possibility to perform distal protection of the infarct-related artery

Exclusion Criteria:

- History of previous myocardial infarction

- Use of fibrinolytic agents for the index infarction

- Left main stenosis

- Heavily calcification of abdominal aorta or occlusive iliofemoral disease hampering access to the coronary ostias by the femoral route

- Known renal failure

- Other significant cardiac disease

- Other severe disease with an expected survival < 1 year

- Known allergy against clopidogrel or contrast media that can not be avoided/limited by medication

- Linguistic difficulties needing an interpreter

- Gastrointestinal bleeding within 1 month

- Childbearing potential or pregnancy

- Participation in another study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
Distal protection and drug eluting stent


Locations

Country Name City State
Denmark Cardiac Cath Lab, Rigshospitalet Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary ST segment resolution 90 min No
Primary Late loss (difference between minimal lumen diameter in stented segment immediately after and at 8 month follow up). immediately after and at 8 month follow up No
Secondary Restenosis 8 months No
Secondary maximal elevations in blood concentrations of CK-MB enzyme and troponin-T Post procedure No
Secondary wall motion index During hospitalisation: day 3-5 No
Secondary Minimal lumen diameter 8 months No
Secondary frequency of binary restenosis (>50% diameter stenosis), diameter stenosis (%) in the stented segment. 8 months No
Secondary Occurrence of stent thrombosis and MACE. 12 months Yes
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