DEDICA (Dose of HEparin During Coronary Angioplasty) Trial

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01694459

Acronym

DEDICA

Enrollment

1000

Registered

2012-09-27

Start date

2010-01-31

Completion date

2012-12-31

Last updated

2012-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

angioplasty, heparin, trial

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.

Interventions

DRUGLow-dose heparin

Bolus of 50 UI/Kg of heparin at the beginning of coronary interventions

DRUGStandard dose heparin

Bolus of 100 UI/Kg of heparin at the beginning of coronary interventional procedure.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Measure	Time frame	Description
Major bleeding	30 days	Major bleeding according to STEEPLE criteria

Countries

Italy

Contacts

Primary ContactVincenzo Pasceri, MD

vpasceri@hotmail.com+39063306

Backup ContactFrancesco Pelliccia, MD

md4151@mclink.it+393483392006

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026