DEDICA (Dose of HEparin During Coronary Angioplasty) Trial

Sponsor

San Filippo Neri General Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01694459

Collaborator

University of Roma La Sapienza (Other)

1,000

Enrollment

Location

Arms

Duration (Months)

28.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Stable Angina Angina, Unstable Non-ST Elevation (NSTEMI) Myocardial Infarction	Drug: Low-dose heparin Drug: Standard dose heparin	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Comparison of Low-dose Heparin Versus Standard Dose Heparin During Coronary Interventions (DEDICA Trial)

Study Start Date :

Jan 1, 2010

Anticipated Primary Completion Date :

Dec 1, 2012

Anticipated Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: 50 UI/Kg bolus heparin

Arm

Intervention/Treatment

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 Names:

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 Names:

50 UI/Kg bolus heparin

Outcome Measures

Primary Outcome Measures

MACE + stent thrombosis + major bleeding (TIMI definition) [30 days]
MACE (death, myocardial infarction, target vessel revascularization) + stent thrombosis + major bleeding (TIMI definition)

Secondary Outcome Measures

MACE [30 days]
MACE = death, myocardial infarction, target vessel revascularization
Major Bleeding [30 days]
Major bleeding according to TIMI criteria
Stent thrombosis [30 days]
Stent thrombosis (definite or probable according to ARC criteria)
CK-MB increase [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)

Other Outcome Measures

Major bleeding [30 days]
Major bleeding according to STEEPLE criteria

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Stable angina, unstable angina or Non-ST elevation myocardial infarction undergoing coronary angioplasty.
Mandatory pretreatment with aspirin and clopidogrel