Stable AnginaPhase 4DEDICANCT01694459
DEDICA (Dose of HEparin During Coronary Angioplasty) Trial
A Phase 4 study testing Low-dose heparin and Standard dose heparin in people with Stable Angina and Angina, Unstable, run by San Filippo Neri General Hospital at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Angina, Angina, Unstable, Non-ST Elevation (NSTEMI) Myocardial Infarction
- What is being tested?
- Low-dose heparin and Standard dose heparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2010to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable angina, unstable angina or Non-ST elevation myocardial infarction undergoing coronary angioplasty.
- Mandatory pretreatment with aspirin and clopidogrel
Who cannot join
- ST elevation myocardial infarction
- Coronary interventions with rotational atherectomy
- Coronary interventions on chronic total occlusions (CTO)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Rome La Sapienza
Rome, 00161
Francesco Pelliccia, MD
Carlo Gaudio, MD
About this study
Official title: 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.
Read the 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.
- Being tested
- Low-dose heparin, Standard dose heparin
- Keywords
- angioplasty, heparin, trial
- Medical subject headings
- Angina, Stable, Angina, Unstable, Non-ST Elevated Myocardial Infarction, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose heparinDrug
Also called 50 UI/Kg bolus heparin
Bolus of 50 UI/Kg of heparin at the beginning of coronary interventions
Standard dose heparinDrug
Also called 100 Ui/Kg bolus heparin
Bolus of 100 UI/Kg of heparin at the beginning of coronary interventional procedure.
| Study group | Role | What they receive |
|---|---|---|
| Standard dose heparin | Active comparator | Bolus of 100 UI/Kg of heparin. Activated clotting time (ACT) > 300 sec. during the procedure Receives: Drug: Standard dose heparin |
| Low-dose heparin | Experimental | Bolus of 50 UI/Kg heparin with a target ACT during the procedure of >200 sec. Receives: Drug: Low-dose heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE + stent thrombosis + major bleeding (TIMI definition)
MACE (death, myocardial infarction, target vessel revascularization) + stent thrombosis + major bleeding (TIMI definition)
Measured: 30 days
Secondary outcomes (4)
MACE
MACE = death, myocardial infarction, target vessel revascularization
Measured: 30 days
Major Bleeding
Major bleeding according to TIMI criteria
Measured: 30 days
Stent thrombosis
Stent thrombosis (definite or probable according to ARC criteria)
Measured: 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)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startJan 2010
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable AnginaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Filippo Neri General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Roma La Sapienza
- Responsible party
- Principal investigator, Vincenzo Pasceri, San Filippo Neri General Hospital
- Investigators
- Vincenzo Pasceri, MD, Study chair, San Filippo Neri HospitalFrancesco Pelliccia, MD, Study director, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694459
- Sponsor's protocol ID
- 596-2012-D
- Acronym
- DEDICA
- Status last verified
- Sep 2012
- First submitted
- 23 Sep 2012
- Last updated
- 27 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Low-dose Heparin Versus Standard Dose Heparin During Coronary Interventions (DEDICA Trial)
- ClinicalTrials.gov ID
- NCT01694459
- Acronym / sponsor ID
- DEDICA / 596-2012-D
- Keywords
- angioplasty, heparin, trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- San Filippo Neri General HospitalUniversity, hospital or other
- Collaborators
- University of Roma La Sapienza
- Study start
- Jan 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 27 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard dose heparin | Active comparator | Drug: Standard dose heparinBolus of 100 UI/Kg of heparin. Activated clotting time (ACT) > 300 sec. during the procedure |
| Low-dose heparin | Experimental | Drug: Low-dose heparinBolus of 50 UI/Kg heparin with a target ACT during the procedure of >200 sec. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stable angina, unstable angina or Non-ST elevation myocardial infarction undergoing coronary angioplasty.
- Mandatory pretreatment with aspirin and clopidogrel
Key exclusion criteria (3 listed)
- ST elevation myocardial infarction
- Coronary interventions with rotational atherectomy
- Coronary interventions on chronic total occlusions (CTO)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-dose heparinAlso: 50 UI/Kg bolus heparinBolus of 50 UI/Kg of heparin at the beginning of coronary interventions | Drug | Low-dose heparin |
| Standard dose heparinAlso: 100 Ui/Kg bolus heparinBolus of 100 UI/Kg of heparin at the beginning of coronary interventional procedure. | Drug | Standard dose heparin |
Primary outcome
MACE + stent thrombosis + major bleeding (TIMI definition)
Time frame: 30 days
MACE (death, myocardial infarction, target vessel revascularization) + stent thrombosis + major bleeding (TIMI definition)
4 secondary outcomes
MACE
Time frame: 30 days
Major Bleeding
Time frame: 30 days
Stent thrombosis
Time frame: 30 days
CK-MB increase
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincenzo Pasceri, MD study chair
San Filippo Neri Hospital
Francesco Pelliccia, MD study director
University of Roma La Sapienza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Low-dose heparin and Standard dose heparin in people with Stable Angina and Angina, Unstable, run by San Filippo Neri General Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincenzo Pasceri, MD (+39063306 ext. 2504, vpasceri@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE + stent thrombosis + major bleeding (TIMI definition) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2012.