MedDataX Logo

DEDICA (Dose of HEparin During Coronary Angioplasty) Trial

NCT ID: NCT01694459

Last Updated: 2012-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

* 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stable Angina Angina, Unstable Non-ST Elevation (NSTEMI) Myocardial Infarction

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

angioplasty heparin trial

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard dose heparin

Bolus of 100 UI/Kg of heparin. Activated clotting time (ACT) \> 300 sec. during the procedure

Group Type ACTIVE_COMPARATOR

Standard dose heparin

Intervention Type DRUG

Bolus of 100 UI/Kg of heparin at the beginning of coronary interventional procedure.

Low-dose heparin

Bolus of 50 UI/Kg heparin with a target ACT during the procedure of \>200 sec.

Group Type EXPERIMENTAL

Low-dose heparin

Intervention Type DRUG

Bolus of 50 UI/Kg of heparin at the beginning of coronary interventions

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Low-dose heparin

Bolus of 50 UI/Kg of heparin at the beginning of coronary interventions

Intervention Type DRUG

Standard dose heparin

Bolus of 100 UI/Kg of heparin at the beginning of coronary interventional procedure.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

50 UI/Kg bolus heparin 100 Ui/Kg bolus heparin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Roma La Sapienza

OTHER

Sponsor Role collaborator

San Filippo Neri General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Vincenzo Pasceri

Attending Cardiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Vincenzo Pasceri, MD

Role: STUDY_CHAIR

San Filippo Neri Hospital

Francesco Pelliccia, MD

Role: STUDY_DIRECTOR

University of Roma La Sapienza

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Rome La Sapienza

Rome, , Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Vincenzo Pasceri, MD

Role: CONTACT

Phone: +39063306

Email: [email protected]

Francesco Pelliccia, MD

Role: CONTACT

Phone: +393483392006

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Francesco Pelliccia, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

596-2012-D

Identifier Type: -

Identifier Source: org_study_id