DEDICA (Dose of HEparin During Coronary Angioplasty) Trial (DEDICA)

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

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.

Study Overview

• Status: Unknown
• Conditions: Angina, Unstable; Stable Angina; Non-ST Elevation (NSTEMI) Myocardial Infarction
• Intervention / Treatment: Drug: Standard dose heparin; Drug: Low-dose heparin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Vincenzo Pasceri, MD; Phone Number: 2504 +39063306; Email: vpasceri@hotmail.com
• Study Contact Backup: Name: Francesco Pelliccia, MD; Phone Number: +393483392006; Email: md4151@mclink.it

Study Locations

• Italy
  • Rome, Italy, 00161
    • Recruiting
    • University of Rome La Sapienza
    • Principal Investigator: Carlo Gaudio, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major bleeding	Major bleeding according to STEEPLE criteria	30 days

Collaborators and Investigators

• Sponsor: San Filippo Neri General Hospital
• Collaborators: University of Roma La Sapienza
• Investigators: Study Chair: Vincenzo Pasceri, MD, San Filippo Neri Hospital; Study Director: Francesco Pelliccia, MD, University of Roma La Sapienza

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (ANTICIPATED): December 1, 2012
• Study Completion (ANTICIPATED): December 1, 2012

Study Registration Dates

• First Submitted: September 23, 2012
• First Submitted That Met QC Criteria: September 26, 2012
• First Posted (ESTIMATE): September 27, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): September 27, 2012
• Last Update Submitted That Met QC Criteria: September 26, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: trial; angioplasty; heparin
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Myocardial Infarction; Infarction; Angina Pectoris; Angina, Stable; Angina, Unstable; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin; Calcium heparin
• Other Study ID Numbers: 596-2012-D