Ischemic Heart DiseasePhase 4RATIONCT02812355
Randomized Anticoagulation Trial in Opcab (RATIO)
A Phase 4 study testing Heparin in people with Ischemic Heart Disease, run by Azienda Ospedaliera di Lecco at 3 sites in 2 countries.
Trial summary
The RATIO Study is a multicenter, nationwide, randomized, controlled, single blinded, unfunded trial of n. 900 patients undergoing multivessel OPCAB (≥2 grafts). This study is designed to test in patients undergoing off-pump coronary artery bypass surgery the hypothesis that full (high dose, 300 U/kg) and half (low… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- Heparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jan 2017to Feb 2019
- 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
- Consecutive patients electively undergoing multivessel OPCAB
Who cannot join
- Acute coronary syndrome, on-going double anti-platelets treatment (the second antiplatelet drug should be suspended 5 days before surgery), on-going intravenous heparin or sub-cutaneous low molecular weight heparin, known coagulopathy, documented liver disease, chronic renal failure (creatinine ≥ 2 mg/dl) or previous renal transplantation surgery, previous cardiac surgery.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Italy2 sites, 2 recruiting
- Recruiting
ASST Lecco
Lecco, 23900
Michele Triggiani, MD, PhD, +390341253066, m.triggiani@asst-lecco.it
- Recruiting
Azienda Ospedaliera Universitaria di Sassari
Sassari
Francesco Massi, MD, fmassi@aslsassari.it
Michele Portoghese, MD
China1 site, 1 recruiting
- Recruiting
Jilin Heart Hospital
Changchun, Jilin
Massimo Lemma, MD, dr.lemma@jlheart.org
Massimo Lemma, MD
About this study
Official title: High Dose Versus Low Dose Heparinization in Patients Undergoing Offpump Coronary Artery Bypass
The RATIO Study is a multicenter, nationwide, randomized, controlled, single blinded, unfunded trial of n. 900 patients undergoing multivessel OPCAB (≥2 grafts). This study is designed to test in patients undergoing off-pump coronary artery bypass surgery the hypothesis that full (high dose, 300 U/kg) and half (low dose,150 U/kg) heparinization are not different in terms of thrombotic complications and major perioperative bleeding events (null hypothesis).
Read the detailed description
Off-pump coronary artery bypass grafting (OPCAB) is an established alternative to on-pump coronary artery bypass grafting (CABG). OPCAB determines a pro-coagulant state potentially deleterious on grafts patency, that is not counterbalanced by the adverse effects of cardiopulmonary bypass on coagulation occurring in CABG, and that lasts as long as one month. Therefore in OPCAB systemic heparinization is necessary to prevent thrombotic complications during transitory occlusion of coronary arteries and grafts. An internationally accepted standard intra-operative anticoagulation protocol for OPCAB has not yet been defined, and heparinization in OPCAB is a highly variable practice. The intraoperative anticoagulation regimen adopted in patients undergoing OPCAB may influence major postoperative outcomes, such as bleeding, transfusion requirements, inflammatory response, myocardial ischemia and grafts patency, but it has never been the object of large-scale randomized controlled trial (RCT). The 2 most widespread intraoperative anticoagulation protocols in OPCAB are represented by full (300 U/kg) or half (150 U/kg) heparinization, with target ACT ranging from 200 sec to >480 sec.
Patients enrolled in the study will be randomized to receive full or half heparinization in a 1:1 ratio using a randomization schedule blocked by site. Randomization will take place in the operatory room by the anesthesiologist, and will be blinded to the surgeon.
- Conditions
- Ischemic Heart Disease
- Being tested
- Heparin
- Keywords
- off-pump, coronary artery bypass, heparinization
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeparinDrug
| Study group | Role | What they receive |
|---|---|---|
| half heparinization | Experimental | heparin I.V. 150 U/kg Receives: Drug: Heparin |
| full heparinization (300 U/kg) | Active comparator | heparin I.V. 300 U/kg Receives: Drug: Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite vascular
Death from vascular causes, perioperative myocardial infarction, stroke.
Measured: 30 days post-operatively
Composite major bleeding
Redo for excessive bleeding, cardiac tamponade, transfusion ≥3 Units of packed red cells or of platelets.
Measured: 48 hours post-operatively
Secondary outcomes (6)
Post-operative bleeding
Total bleeding evaluated the morning after surgery (ml.)
Measured: 48 hours post-operatively
Transfusion of packed red cells (<3 Units) or of platelets
Measured: 30 days post-operatively
Peak value of cardiac biomarker
Measured: 30 days post-operatively
Transient ischemic cerebral attack
Measured: 30 days post-operatively
Mesenteric ischemia (angiography or CT scan)
Measured: 30 days post-operatively
Pulmonary embolus (angiography or CT scan)
Measured: 30 days post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startJan 2017
- Primary completionJan 2019 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies 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
- Investigator
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera di Lecco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Triggiani, Azienda Ospedaliera di Lecco
- Investigators
- Michele NR Triggiani, MD, PhD, Principal investigator, ASST Lecco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812355
- Sponsor's protocol ID
- EudraCT n. 2016-001529-15
- Acronym
- RATIO
- Status last verified
- May 2017
- First submitted
- 22 Jun 2016
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Dose Versus Low Dose Heparinization in Patients Undergoing Offpump Coronary Artery Bypass
- ClinicalTrials.gov ID
- NCT02812355
- Acronym / sponsor ID
- RATIO / EudraCT n. 2016-001529-15
- Conditions
- Ischemic Heart Disease
- Keywords
- off-pump, coronary artery bypass, heparinization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera di LeccoUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 24 Jun 2016 (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.
The RATIO Study is a multicenter, nationwide, randomized, controlled, single blinded, unfunded trial of n. 900 patients undergoing multivessel OPCAB (≥2 grafts). This study is designed to test in patients undergoing off-pump coronary artery bypass surgery the hypothesis that full (high dose, 300 U/kg) and half (low dose,150 U/kg) heparinization are not different in terms of thrombotic complications and major perioperative bleeding events (null hypothesis).
Detailed description
Off-pump coronary artery bypass grafting (OPCAB) is an established alternative to on-pump coronary artery bypass grafting (CABG). OPCAB determines a pro-coagulant state potentially deleterious on grafts patency, that is not counterbalanced by the adverse effects of cardiopulmonary bypass on coagulation occurring in CABG, and that lasts as long as one month. Therefore in OPCAB systemic heparinization is necessary to prevent thrombotic complications during transitory occlusion of coronary arteries and grafts. An internationally accepted standard intra-operative anticoagulation protocol for OPCAB has not yet been defined, and heparinization in OPCAB is a highly variable practice. The intraoperative anticoagulation regimen adopted in patients undergoing OPCAB may influence major postoperative outcomes, such as bleeding, transfusion requirements, inflammatory response, myocardial ischemia and grafts patency, but it has never been the object of large-scale randomized controlled trial (RCT). The 2 most widespread intraoperative anticoagulation protocols in OPCAB are represented by full (300 U/kg) or half (150 U/kg) heparinization, with target ACT ranging from 200 sec to >480 sec.
Patients enrolled in the study will be randomized to receive full or half heparinization in a 1:1 ratio using a randomization schedule blocked by site. Randomization will take place in the operatory room by the anesthesiologist, and will be blinded to the surgeon.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| half heparinization | Experimental | Drug: Heparinheparin I.V. 150 U/kg |
| full heparinization (300 U/kg) | Active comparator | Drug: Heparinheparin I.V. 300 U/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive patients electively undergoing multivessel OPCAB
Key exclusion criteria (1 listed)
- Acute coronary syndrome, on-going double anti-platelets treatment (the second antiplatelet drug should be suspended 5 days before surgery), on-going intravenous heparin or sub-cutaneous low molecular weight heparin, known coagulopathy, documented liver disease, chronic renal failure (creatinine ≥ 2 mg/dl) or previous renal transplantation surgery, previous cardiac surgery.
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 |
|---|---|---|
| Heparin | Drug | full heparinization (300 U/kg), half heparinization |
Primary outcome
Composite vascular
Time frame: 30 days post-operatively
Death from vascular causes, perioperative myocardial infarction, stroke.
Composite major bleeding
Time frame: 48 hours post-operatively
Redo for excessive bleeding, cardiac tamponade, transfusion ≥3 Units of packed red cells or of platelets.
6 secondary outcomes
Post-operative bleeding
Time frame: 48 hours post-operatively
Transfusion of packed red cells (<3 Units) or of platelets
Time frame: 30 days post-operatively
Peak value of cardiac biomarker
Time frame: 30 days post-operatively
Transient ischemic cerebral attack
Time frame: 30 days post-operatively
Mesenteric ischemia (angiography or CT scan)
Time frame: 30 days post-operatively
Pulmonary embolus (angiography or CT scan)
Time frame: 30 days post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
- Individual participant dataSharing planned: No
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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.
Michele NR Triggiani, MD, PhD principal investigator
ASST Lecco
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Heparin in people with Ischemic Heart Disease, run by Azienda Ospedaliera di Lecco at 3 sites in 2 countries.
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 1 inclusion and 1 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 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy, China. 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 Michele NR Triggiani, MD, PhD (+39-0341253066, m.triggiani@asst-lecco.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite vascular (time frame: 30 days post-operatively). The study lists 2 primary outcomes in all. 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 12 May 2017.