DEDICA (Dose of HEparin During Coronary Angioplasty) Trial

Phase 4

• Conditions: Stable Angina; Angina, Unstable; Non-ST Elevation (NSTEMI) Myocardial Infarction
• Interventions: Drug: Low-dose heparin; Drug: Standard dose heparin

• Registration Number: NCT01694459
• Lead Sponsor: San Filippo Neri General Hospital

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.

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 Timeline

• Study Start: 2010-01
• Status Verified: 2012-09
• Study First Submitted: 2012-09-23
• Study First Submitted QC: 2012-09-26
• Last Update Submitted: 2012-09-26
• Study First Posted: 2012-09-27
• Last Update Posted: 2012-09-27
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-dose heparin	Low-dose heparin	Bolus of 50 UI/Kg heparin with a target ACT during the procedure of \>200 sec.
Standard dose heparin	Standard dose heparin	Bolus of 100 UI/Kg of heparin. Activated clotting time (ACT) \> 300 sec. during the procedure

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

University of Rome La Sapienza; 🇮🇹 Rome, Italy