DEDICA (Dose of HEparin During Coronary Angioplasty) Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by San Filippo Neri General Hospital
Sponsor:
Collaborator:
University of Roma La Sapienza
Information provided by (Responsible Party):
Vincenzo Pasceri, San Filippo Neri General Hospital
ClinicalTrials.gov Identifier:
NCT01694459
First received: September 23, 2012
Last updated: September 26, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Stable Angina
Angina, Unstable
Non-ST Elevation (NSTEMI) Myocardial Infarction
Drug: Low-dose heparin
Drug: Standard dose heparin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison of Low-dose Heparin Versus Standard Dose Heparin During Coronary Interventions (DEDICA Trial)

Resource links provided by NLM:


Further study details as provided by San Filippo Neri General Hospital:

Primary Outcome Measures:
  • MACE + stent thrombosis + major bleeding (TIMI definition) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    MACE (death, myocardial infarction, target vessel revascularization) + stent thrombosis + major bleeding (TIMI definition)


Secondary Outcome Measures:
  • MACE [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    MACE = death, myocardial infarction, target vessel revascularization

  • Major Bleeding [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Major bleeding according to TIMI criteria

  • Stent thrombosis [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Stent thrombosis (definite or probable according to ARC criteria)

  • CK-MB increase [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Any CK MB increase >3 times upper limit of normal or >50% baseline levels (if baseline levels already >then upper limit of normal)


Other Outcome Measures:
  • Major bleeding [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Major bleeding according to STEEPLE criteria


Estimated Enrollment: 1000
Study Start Date: January 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 50 UI/Kg bolus 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01694459

Contacts
Contact: Vincenzo Pasceri, MD +39063306 ext 2504 vpasceri@hotmail.com
Contact: Francesco Pelliccia, MD +393483392006 md4151@mclink.it

Locations
Italy
University of Rome La Sapienza Recruiting
Rome, Italy, 00161
Contact: Francesco Pelliccia, MD         
Principal Investigator: Carlo Gaudio, MD         
Sponsors and Collaborators
San Filippo Neri General Hospital
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
  More Information

No publications provided

Responsible Party: Vincenzo Pasceri, Attending Cardiologist, San Filippo Neri General Hospital
ClinicalTrials.gov Identifier: NCT01694459     History of Changes
Other Study ID Numbers: 596-2012-D
Study First Received: September 23, 2012
Last Updated: September 26, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by San Filippo Neri General Hospital:
angioplasty
heparin
trial

Additional relevant MeSH terms:
Angina Pectoris
Angina, Unstable
Infarction
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Ischemia
Pathologic Processes
Necrosis
Calcium heparin
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 23, 2014