DEDICA (Dose of HEparin During Coronary Angioplasty) Trial

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Drug: Low-dose heparin
* Drug: Standard dose heparin


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard dose heparin<br>Bolus of 100 UI/Kg of heparin. Activated clotting time (ACT) > 300 sec. during the procedure | Drug: Standard dose heparin<br>* Bolus of 100 UI/Kg of heparin at the beginning of coronary interventional procedure.<br>* Other names: 100 Ui/Kg bolus heparin;|
| Experimental: Low-dose heparin<br>Bolus of 50 UI/Kg heparin with a target ACT during the procedure of >200 sec. | Drug: Low-dose heparin<br>* Bolus of 50 UI/Kg of heparin at the beginning of coronary interventions<br>* Other names: 50 UI/Kg bolus heparin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE + stent thrombosis + major bleeding (TIMI definition) | MACE (death, myocardial infarction, target vessel revascularization) + stent thrombosis + major bleeding (TIMI definition) | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE | MACE = death, myocardial infarction, target vessel revascularization | 30 days | 
| Major Bleeding | Major bleeding according to TIMI criteria | 30 days | 
| Stent thrombosis | Stent thrombosis (definite or probable according to ARC criteria) | 30 days | 
| CK-MB increase | Any CK MB increase >3 times upper limit of normal or >50% baseline levels (if baseline levels already >then upper limit of normal) | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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angioplasty, heparin, trial