Antiplatelet Therapy of Coronary Artery BypassPhase 4ATCCCNCT02330640
A Single-center, Prospective,Randomized Study of Antiplatelet Effects of Ticagrelor Versus Clopidogrel in Patients With Dual Anti-platelet Therapy After Coronary Artery Bypass Grafting
A Phase 4 study testing ticagrelor, clopidogrel and asprin in people with Antiplatelet Therapy of Coronary Artery Bypass, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
This study is designed to demonstrate that the onset of the antiplatelet effect of 90mg bid dose ticagrelor is more rapid and greater than 75 mg qd dose clopidogrel in patients undergoing CABG surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Antiplatelet Therapy of Coronary Artery Bypass
- What is being tested?
- ticagrelor, clopidogrel and asprin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to 1 Oct 2016
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female and/or male and ≥ 18 and <80 years of age
- Isolated CABG for the first time
- either on- or off- pump
Who cannot join
- Combined valvular surgery.
- A second surgery.
- Emergency surgery (a selective operation which change to emergency surgery in some special medical condition).
- Serum creatinine>130μmol/L.
- Oral clopidogrel therapy stops less than 5 days before the surgery.
- Oral anti-coagulation therapy (warfarin) that cannot be withheld.
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- History of gastrointestinal or vaginal bleeding, Active pathological bleeding (e.g. active gastroduodenal ulcer or cerebral haemorrhage), history of postoperative gastrointestinal bleeding.
- Uric acid nephropathy, history of postoperative gastrointestinal bleeding.
- History of cerebral haemorrhage.
- Any other condition that may influence platelet count and function.
- Postoperative chest drainage > 200 ml/hr for two hours and more, re-operation for bleeding with persistent cardiac tamponade.
- Treated with IABP or ECMO after operation.
- Any other condition that may put the patient at risk (e.g., recurrent ventricular arrhythmias, peri-operative myocardial infarction, cancer).
- Contraindication to aspirin, clopidogrel and ticagrelor or other reason that study drug should not be administered (e.g., hypersensitivity, moderate or severe liver disease).
- Previous enrollment in other investigational drug or device study within 30 days.
- Being or planning to pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed to demonstrate that the onset of the antiplatelet effect of 90mg bid dose ticagrelor is more rapid and greater than 75 mg qd dose clopidogrel in patients undergoing CABG surgery.
Read the detailed description
Patients undergoing coronary artery surgery routinely receive aspirin therapy, as a standard treatment for preserving bypass graft patency. Although the dual antiplatelet therapy post CABG has not been recommended by guideline, present studies indicated the patients could benefit from the dual anti-platelet therapy. Using clopidogrel+aspirin could significantly reduce the early saphenous vein graft occlusion. . Many surgeons empirically prescribe dual anti-platelet therapy in spite of the indeterminacy of the clinical effects. ticagrelor is a novel, reversibly binding, oral, direct-acting P2Y12-receptor antagonist. The ONSET/OFFSET Study also shows that ticagrelor achieved much rapid and greater platelet inhibition than high-loading-dose clopidogrel in patients with stable CAD. ticagrelor is a novel, reversibly binding, oral, direct-acting P2Y12-receptor antagonist. The ONSET/OFFSET Study also shows that ticagrelor achieved much rapid and greater platelet inhibition than high-loading-dose clopidogrel in patients with stable CAD.
- Being tested
- ticagrelor, clopidogrel, asprin
- Keywords
- CABG, antiplatelet therapy, ticagrelor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ticagrelorDrug
After the operation, the subjects will be randomized into two groups according to the proportion of 1:1; and receive the treatment of aspirin 100mg qd+ticagrelor 90mg bid or the treatment of aspirin 100mg qd+ clopidogrel 75mg qd. The study will plan to enroll 140 subjects in 12 months and the treatment will last for 30 days.
clopidogrelDrug
After the operation, the subjects will be randomized into two groups according to the proportion of 1:1; and receive the treatment of aspirin 100mg qd+ticagrelor 90mg bid or the treatment of aspirin 100mg qd+ clopidogrel 75mg qd. The study will plan to enroll 140 subjects in 12 months and the treatment will last for 30 days.
asprinDrug
All patients will be given asprin 100mg Qd within 24hours after operation,and will continue taking aspirin at the end of the study
| Study group | Role | What they receive |
|---|---|---|
| ticagrelor | Experimental | 90mg Bid for 30days after first dose Receives: Drug: ticagrelor |
| clopidogrel | Active comparator | 75mg Qd for 30days first dose Receives: Drug: clopidogrel |
| asprin | Other | 100mg Qd all patients will be given asprin 100mg Qd within 24hours after CABG Receives: Drug: asprin |
What is being measured
The primary outcome is the main question the study is designed to answer.
IPA at 2hours
the platelet inhibition (IPA %) measured by light-transmittance aggregometry at 2 hour in CABG patients after the first dose of study drug
Measured: 2 hours after the first dose of study drug
Secondary outcomes (2)
the inhibition of platelet function (IPA%) measured by LTA at 0h, 8h, 24h, 3day, and 30day after the first dose of study drug
the platelet inhibition (IPA %) measured by light-transmittance aggregometry at 0h, 8h, 24h, 3day, and 30day after the first dose of study drug
Measured: 0h, 8h, 24h, 3day, and 30day after the first dose of study drug
the platelet reactivity index at 0h, 2h, 8h, 24h，3day, and 30days
the platelet reactivity index measured by corrected mean fluorescence intensities (MFIc) at 0h, 2h, 8h, 24h，3day, and 30day after the first dose of study drug in CABG patients.
Measured: 0h, 2h, 8h, 24h，3day, and 30day after the first dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2015 (estimated)
- Study startJan 2016
- Primary completionOct 2016
- Study completion1 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antiplatelet Therapy of Coronary Artery BypassStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- 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
- Model description
- Single center prospective randomized controlled study
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhe zheng, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02330640
- Sponsor's protocol ID
- Zzheng
- Acronym
- ATCCC
- Status last verified
- May 2017
- First submitted
- 24 Dec 2014
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Prospective,Randomized Study of Antiplatelet Effects of Ticagrelor Versus Clopidogrel in Patients With Dual Anti-platelet Therapy After Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT02330640
- Acronym / sponsor ID
- ATCCC / Zzheng
- Keywords
- CABG, antiplatelet therapy, ticagrelor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- 1 Oct 2016 (actual)
- First posted
- 5 Jan 2015 (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.
This study is designed to demonstrate that the onset of the antiplatelet effect of 90mg bid dose ticagrelor is more rapid and greater than 75 mg qd dose clopidogrel in patients undergoing CABG surgery.
Detailed description
Patients undergoing coronary artery surgery routinely receive aspirin therapy, as a standard treatment for preserving bypass graft patency. Although the dual antiplatelet therapy post CABG has not been recommended by guideline, present studies indicated the patients could benefit from the dual anti-platelet therapy. Using clopidogrel+aspirin could significantly reduce the early saphenous vein graft occlusion. . Many surgeons empirically prescribe dual anti-platelet therapy in spite of the indeterminacy of the clinical effects. ticagrelor is a novel, reversibly binding, oral, direct-acting P2Y12-receptor antagonist. The ONSET/OFFSET Study also shows that ticagrelor achieved much rapid and greater platelet inhibition than high-loading-dose clopidogrel in patients with stable CAD. ticagrelor is a novel, reversibly binding, oral, direct-acting P2Y12-receptor antagonist. The ONSET/OFFSET Study also shows that ticagrelor achieved much rapid and greater platelet inhibition than high-loading-dose clopidogrel in patients with stable CAD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Single center prospective randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| ticagrelor | Experimental | Drug: ticagrelor90mg Bid for 30days after first dose |
| clopidogrel | Active comparator | Drug: clopidogrel75mg Qd for 30days first dose |
| asprin | Other | Drug: asprin100mg Qd all patients will be given asprin 100mg Qd within 24hours after CABG |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female and/or male and ≥ 18 and <80 years of age
- Isolated CABG for the first time
- either on- or off- pump
Key exclusion criteria (16 listed)
- Combined valvular surgery.
- A second surgery.
- Emergency surgery (a selective operation which change to emergency surgery in some special medical condition).
- Serum creatinine>130μmol/L.
- Oral clopidogrel therapy stops less than 5 days before the 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 |
|---|---|---|
| ticagrelorAfter the operation, the subjects will be randomized into two groups according to the proportion of 1:1; and receive the treatment of aspirin 100mg qd+ticagrelor 90mg bid or the treatment of aspirin 100mg qd+ clopidogrel 75mg qd. The study will plan to enroll 140 subjects in 12 months and the treatment will last for 30 days. | Drug | ticagrelor |
| clopidogrelAfter the operation, the subjects will be randomized into two groups according to the proportion of 1:1; and receive the treatment of aspirin 100mg qd+ticagrelor 90mg bid or the treatment of aspirin 100mg qd+ clopidogrel 75mg qd. The study will plan to enroll 140 subjects in 12 months and the treatment will last for 30 days. | Drug | clopidogrel |
| asprinAll patients will be given asprin 100mg Qd within 24hours after operation,and will continue taking aspirin at the end of the study | Drug | asprin |
Primary outcome
IPA at 2hours
Time frame: 2 hours after the first dose of study drug
the platelet inhibition (IPA %) measured by light-transmittance aggregometry at 2 hour in CABG patients after the first dose of study drug
2 secondary outcomes
the inhibition of platelet function (IPA%) measured by LTA at 0h, 8h, 24h, 3day, and 30day after the first dose of study drug
Time frame: 0h, 8h, 24h, 3day, and 30day after the first dose of study drug
the platelet reactivity index at 0h, 2h, 8h, 24h，3day, and 30days
Time frame: 0h, 2h, 8h, 24h，3day, and 30day after the first dose of study drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 ticagrelor, clopidogrel and asprin in people with Antiplatelet Therapy of Coronary Artery Bypass, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
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 3 inclusion and 16 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: finished, as of the sponsor's last update on 9 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 1 site in 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IPA at 2hours (time frame: 2 hours after the first dose of study drug). 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 9 May 2017.