NCT01694459|UnknownPhase 4
DEDICA (Dose of HEparin During Coronary Angioplasty) Trial
DEDICA
Comparison of Low-dose Heparin Versus Standard Dose Heparin During Coronary Interventions (DEDICA Trial)
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DEDICA
Comparison of Low-dose Heparin Versus Standard Dose Heparin During Coronary Interventions (DEDICA Trial)
Sponsor study identifier
interventional
1,000
1 country
1
Study Start
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
International guidelines support the use of a full-dose heparin (anticoagulants) during coronary intervention. However, a lower dose of heparin may be adequate, thanks to advances in angioplasty techniques and the widespread use of pretreatment with two antiplatelet agents. Thus the investigators designed a study comparing safety and efficacy of standard dose heparin (100 UI/Kg) versus low-dose (50 UI/Kg) in patients undergoing coronary angioplasty who are on aspirin and clopidogrel at the time of the procedure.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
September 23, 2012
Actual (reported)September 27, 2012
Actual (reported)December 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
MACE + stent thrombosis + major bleeding (TIMI definition)
MACE (death, myocardial infarction, target vessel revascularization) + stent thrombosis + major bleeding (TIMI definition)
30 days
MACE
30 days
Major Bleeding
30 days
Stent thrombosis
30 days
CK-MB increase
30 days
Major bleeding
30 days
Bolus of 100 UI/Kg of heparin. Activated clotting time (ACT) \> 300 sec. during the procedure
Bolus of 50 UI/Kg heparin with a target ACT during the procedure of \>200 sec.
Bolus of 50 UI/Kg of heparin at the beginning of coronary interventions
Bolus of 100 UI/Kg of heparin at the beginning of coronary interventional procedure.
University of Rome La Sapienza
Rome, 00161, Italy
Vincenzo Pasceri, MD
San Filippo Neri Hospital
Francesco Pelliccia, MD
University of Roma La Sapienza
First Submitted
September 23, 2012
First Posted
September 27, 2012
Study Start
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2012
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 27, 2012
Record last verified: 2012-09
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Source: ClinicalTrials.gov.
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