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DEDICA (Dose of HEparin During Coronary Angioplasty) Trial

Information source: San Filippo Neri General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Stable Angina; Angina, Unstable; Non-ST Elevation (NSTEMI) Myocardial Infarction

Intervention: Low-dose heparin (Drug); Standard dose heparin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: San Filippo Neri General Hospital

Official(s) and/or principal investigator(s):
Vincenzo Pasceri, MD, Study Chair, Affiliation: San Filippo Neri Hospital
Francesco Pelliccia, MD, Study Director, Affiliation: University of Roma La Sapienza

Overall contact:
Vincenzo Pasceri, MD, Phone: +39063306, Ext: 2504, Email: vpasceri@hotmail.com

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.

Clinical Details

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

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

Primary outcome: MACE + stent thrombosis + major bleeding (TIMI definition)

Secondary outcome:

MACE

Major Bleeding

Stent thrombosis

CK-MB increase

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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)

Locations and Contacts

Vincenzo Pasceri, MD, Phone: +39063306, Ext: 2504, Email: vpasceri@hotmail.com

University of Rome La Sapienza, Rome 00161, Italy; Recruiting
Francesco Pelliccia, MD
Carlo Gaudio, MD, Principal Investigator
Additional Information

Starting date: January 2010
Last updated: September 26, 2012

Page last updated: August 23, 2015

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