DEDICA (Dose of HEparin During Coronary Angioplasty) Trial (DEDICA)
Recruitment status was: Recruiting
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.
|Stable Angina Angina, Unstable Non-ST Elevation (NSTEMI) Myocardial Infarction||Drug: Low-dose heparin Drug: Standard dose heparin||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
|Official Title:||Comparison of Low-dose Heparin Versus Standard Dose Heparin During Coronary Interventions (DEDICA Trial)|
- MACE + stent thrombosis + major bleeding (TIMI definition) [ Time Frame: 30 days ]MACE (death, myocardial infarction, target vessel revascularization) + stent thrombosis + major bleeding (TIMI definition)
- MACE [ Time Frame: 30 days ]MACE = death, myocardial infarction, target vessel revascularization
- Major Bleeding [ Time Frame: 30 days ]Major bleeding according to TIMI criteria
- Stent thrombosis [ Time Frame: 30 days ]Stent thrombosis (definite or probable according to ARC criteria)
- CK-MB increase [ Time Frame: 30 days ]Any CK MB increase >3 times upper limit of normal or >50% baseline levels (if baseline levels already >then upper limit of normal)
- Major bleeding [ Time Frame: 30 days ]Major bleeding according to STEEPLE criteria
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Standard dose heparin
Bolus of 100 UI/Kg of heparin. Activated clotting time (ACT) > 300 sec. during the procedure
Drug: Standard dose heparin
Bolus of 100 UI/Kg of heparin at the beginning of coronary interventional procedure.
Other Name: 100 Ui/Kg bolus heparin
Experimental: Low-dose heparin
Bolus of 50 UI/Kg heparin with a target ACT during the procedure of >200 sec.
Drug: Low-dose heparin
Bolus of 50 UI/Kg of heparin at the beginning of coronary interventions
Other Name: 50 UI/Kg bolus heparin
- Patients undergoing coronary angioplasty will be randomised to standard vs. low-dose heparin. the study will include "all-comers" (patients with either stable angina or acute coronary syndromes); only patients with ST-elevation myocardial infarction will be excluded.
- An ACT (activated clotting time) will be performed after the initial bolus of heparin: for the standard dose group the target ACT will be > 300 sec. (as recommended by guidelines) while for the low-dose the target ACT will be > 180 sec.
Aim of the study is to show equivalence in ischemic events between the two doses of heparin, in order to confirm the safety of lower dose of heparin in contemporary coronary interventions.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01694459
|Contact: Vincenzo Pasceri, MD||+39063306 ext firstname.lastname@example.org|
|Contact: Francesco Pelliccia, MDemail@example.com|
|University of Rome La Sapienza||Recruiting|
|Rome, Italy, 00161|
|Contact: Francesco Pelliccia, MD|
|Principal Investigator: Carlo Gaudio, MD|
|Study Chair:||Vincenzo Pasceri, MD||San Filippo Neri Hospital|
|Study Director:||Francesco Pelliccia, MD||University of Roma La Sapienza|