DEDICA (Dose of HEparin During Coronary Angioplasty) Trial

Stable Angina Clinical Trial

— DEDICA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01694459
• Other study ID #: 596-2012-D
• Status: Recruiting
• Phase: Phase 4
• First received: September 23, 2012
• Last updated: September 26, 2012
• Start date: January 2010
• Est. completion date: December 2012

Study information

• Verified date: September 2012
• Source: San Filippo Neri General Hospital
• Contact: Vincenzo Pasceri, MD
• Phone: +39063306
• Email: vpasceri[@]hotmail.com
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Low-dose heparin
Bolus of 50 UI/Kg of heparin at the beginning of coronary interventions
• Standard dose heparin
Bolus of 100 UI/Kg of heparin at the beginning of coronary interventional procedure.

Locations

Country	Name	City	State
Italy	University of Rome La Sapienza	Rome

Sponsors (2)

Lead Sponsor	Collaborator
San Filippo Neri General Hospital	University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Major bleeding	Major bleeding according to STEEPLE criteria	30 days	Yes
Primary	MACE + stent thrombosis + major bleeding (TIMI definition)	MACE (death, myocardial infarction, target vessel revascularization) + stent thrombosis + major bleeding (TIMI definition)	30 days	Yes
Secondary	MACE	MACE = death, myocardial infarction, target vessel revascularization	30 days	No
Secondary	Major Bleeding	Major bleeding according to TIMI criteria	30 days	Yes
Secondary	Stent thrombosis	Stent thrombosis (definite or probable according to ARC criteria)	30 days	Yes
Secondary	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	No