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: MACEMajor 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
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