DEDICA (Dose of HEparin During Coronary Angioplasty) Trial

San Filippo Neri General Hospital

Status and phase: Unknown; Phase 4

Conditions: Non-ST Elevation (NSTEMI) Myocardial Infarction; Stable Angina; Angina, Unstable

Treatments: Drug: Low-dose heparin; Drug: Standard dose heparin

Study type: Interventional

Funder types: Other

Identifiers

NCT01694459

596-2012-D

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• ST elevation myocardial infarction
• Coronary interventions with rotational atherectomy
• Coronary interventions on chronic total occlusions (CTO)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,000 participants in 2 patient groups

Standard dose heparin

Active Comparator group

Description:

Bolus of 100 UI/Kg of heparin. Activated clotting time (ACT) \> 300 sec. during the procedure

Treatment:

Drug: Standard dose heparin

Low-dose heparin

Experimental group

Description:

Bolus of 50 UI/Kg heparin with a target ACT during the procedure of \>200 sec.

Treatment:

Drug: Low-dose heparin