Drug Elution and Distal Protection During Percutaneous Coronary Intervention in ST Elevation Myocardial Infarction
NCT ID: NCT00192868
Last Updated: 2009-09-23
Study Results
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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UNKNOWN
NA
600 participants
INTERVENTIONAL
2005-05-31
2011-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Distal protection and drug eluting stent
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Principal Investigators
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Henning Kelbaek, MD
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Locations
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Cardiac Cath Lab, Rigshospitalet
Copenhagen, , Denmark
Countries
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References
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Kaltoft A, Kelbaek H, Thuesen L, Lassen JF, Clemmensen P, Klovgaard L, Engstrom T, Botker HE, Saunamaki K, Krusell LR, Jorgensen E, Tilsted HH, Christiansen EH, Ravkilde J, Kober L, Kofoed KF, Terkelsen CJ, Helqvist S. Long-term outcome after drug-eluting versus bare-metal stent implantation in patients with ST-segment elevation myocardial infarction: 3-year follow-up of the randomized DEDICATION (Drug Elution and Distal Protection in Acute Myocardial Infarction) Trial. J Am Coll Cardiol. 2010 Aug 17;56(8):641-5. doi: 10.1016/j.jacc.2010.05.009.
Kaltoft A, Kelbaek H, Klovgaard L, Terkelsen CJ, Clemmensen P, Helqvist S, Lassen JF, Thuesen L. Increased rate of stent thrombosis and target lesion revascularization after filter protection in primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: 15-month follow-up of the DEDICATION (Drug Elution and Distal Protection in ST Elevation Myocardial Infarction) trial. J Am Coll Cardiol. 2010 Mar 2;55(9):867-71. doi: 10.1016/j.jacc.2009.09.052.
Kelbaek H, Thuesen L, Helqvist S, Clemmensen P, Klovgaard L, Kaltoft A, Andersen B, Thuesen H, Engstrom T, Botker HE, Saunamaki K, Krusell LR, Jorgensen E, Hansen HH, Christiansen EH, Ravkilde J, Kober L, Kofoed KF, Terkelsen CJ, Lassen JF; DEDICATION Investigators. Drug-eluting versus bare metal stents in patients with st-segment-elevation myocardial infarction: eight-month follow-up in the Drug Elution and Distal Protection in Acute Myocardial Infarction (DEDICATION) trial. Circulation. 2008 Sep 9;118(11):1155-62. doi: 10.1161/CIRCULATIONAHA.107.758698. Epub 2008 Aug 25.
Kelbaek H, Terkelsen CJ, Helqvist S, Lassen JF, Clemmensen P, Klovgaard L, Kaltoft A, Engstrom T, Botker HE, Saunamaki K, Krusell LR, Jorgensen E, Hansen HH, Christiansen EH, Ravkilde J, Kober L, Kofoed KF, Thuesen L. Randomized comparison of distal protection versus conventional treatment in primary percutaneous coronary intervention: the drug elution and distal protection in ST-elevation myocardial infarction (DEDICATION) trial. J Am Coll Cardiol. 2008 Mar 4;51(9):899-905. doi: 10.1016/j.jacc.2007.10.047.
Other Identifiers
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DEDICATION
Identifier Type: -
Identifier Source: org_study_id
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