DEDICA (Dose of HEparin During Coronary Angioplasty) Trial
DEDICA
Comparison of Low-dose Heparin Versus Standard Dose Heparin During Coronary Interventions (DEDICA Trial)
1 other identifier
interventional
1,000
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2010
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 23, 2012
CompletedFirst Posted
Study publicly available on registry
September 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedSeptember 27, 2012
September 1, 2012
2.9 years
September 23, 2012
September 26, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
MACE + stent thrombosis + major bleeding (TIMI definition)
MACE (death, myocardial infarction, target vessel revascularization) + stent thrombosis + major bleeding (TIMI definition)
30 days
Secondary Outcomes (4)
MACE
30 days
Major Bleeding
30 days
Stent thrombosis
30 days
CK-MB increase
30 days
Other Outcomes (1)
Major bleeding
30 days
Study Arms (2)
Standard dose heparin
ACTIVE COMPARATORBolus of 100 UI/Kg of heparin. Activated clotting time (ACT) \> 300 sec. during the procedure
Low-dose heparin
EXPERIMENTALBolus of 50 UI/Kg heparin with a target ACT during the procedure of \>200 sec.
Interventions
Bolus of 50 UI/Kg of heparin at the beginning of coronary interventions
Bolus of 100 UI/Kg of heparin at the beginning of coronary interventional procedure.
Eligibility Criteria
You may qualify if:
- Stable angina, unstable angina or Non-ST elevation myocardial infarction undergoing coronary angioplasty.
- Mandatory pretreatment with aspirin and clopidogrel
You may not qualify if:
- ST elevation myocardial infarction
- Coronary interventions with rotational atherectomy
- Coronary interventions on chronic total occlusions (CTO)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- San Filippo Neri General Hospitallead
- University of Roma La Sapienzacollaborator
Study Sites (1)
University of Rome La Sapienza
Rome, 00161, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Vincenzo Pasceri, MD
San Filippo Neri Hospital
- STUDY DIRECTOR
Francesco Pelliccia, MD
University of Roma La Sapienza
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Cardiologist
Study Record Dates
First Submitted
September 23, 2012
First Posted
September 27, 2012
Study Start
January 1, 2010
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
September 27, 2012
Record last verified: 2012-09