AzTrials
AzTrials

Coronary Artery BypassPhase 4DACABNCT02201771

Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Graft Surgery

A Phase 4 study testing Aspirin and Ticagrelor in people with Coronary Artery Bypass and Antiplatelet Agents, run by Ruijin Hospital at 6 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The study population will include all patients undergoing elective CABG. Consent and randomization will occur before surgery. Total 500 patients undergoing elective CABG will be randomly assigned into three groups with 1:1:1 ratio(167 patients per group) in this open-label study. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Coronary Artery Bypass, Antiplatelet Agents
What is being tested?
Aspirin and Ticagrelor
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
6 sitesChina
Study dates
Jul 2014to Jan 2017
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Patients able to provide written informed consent
  • Provision of informed consent prior to any study specific procedures
  • Female and male patients aged 18-80 years
  • Indication for CABG surgery

Who cannot join

  • Cardiogenic shock, haemodynamic instability
  • Need for urgent revascularization within 5 days from presentation
  • Single vessel disease
  • Two vessel disease with normal left ventricular function (> 50%)
  • Need for concomitant other cardiac surgery (e.g. valve replacement)
  • Need for dual antiplatelet treatment for the patients undergoing CABG after acute coronary syndrome(ACS)
Show all 23Show fewer
  • Contraindication for aspirin and ticagrelor use(e.g. known allergy)
  • History of bleeding diathesis within 3 months prior presentation
  • History of significant GI bleed within 1 year prior presentation
  • History of peptic ulcer without GI bleeding in past 3 years
  • History of intracranial hemorrhage
  • History of moderate to severe liver impairment
  • Patient requires dialysis
  • Patient with an increased risk of bradycardic events (as patients without a pacemaker who have sick sinus syndrome, 2nd or 3rd degree arteriolar-venular block or bradycardic-related syncope)
  • Need vitamin K antagonist therapy after bypass surgery eg. persistent atrial fibrillation, mechanical valves
  • Known, clinically important thrombocytopenia(i.e. < 100*109/L)
  • Known, clinically important anaemia (i.e. <100g/L)
  • Participation in another investigational drug or device study in the last 30 days
  • Pregnancy or lactation(for premenopausal women 2 methods of reliable contraception, one of which must barrier method, are required)
  • Concomitant oral or intravenous therapy with strong cytochrome P450 3A4(CYP3A4) inhibitors, CYP3A4 substrates with narrow therapeutic indices, or strong CYP3A4 inducers which cannot be stopped for the course of the study (strong inhibitors: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, over 1 litre daily of grapefruit juice. Substrates with narrow therapeutic index: cyclosporine, quinidine. Strong inducers: rifampin, phenytoin, carbamazepine. )
  • Any other condition such as active cancer
  • Life expectancy less than 12 months that may result in protocol non-compliance or a risk for being lost to follow up
  • Indication for major surgery(e.g. cancer treatment, carotid surgery, cerebral surgery, major vascular surgery)

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • Jiangsu Province Hospital

    Nanjing, Jiangsu

  • Nan Jing First Hospital

    Nanjing, Jiangsu

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

  • Xinhua Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200092

  • Changhai Hospital of Shanghai

    Shanghai, Shanghai Municipality, 200433

  • Henan Provincial People's Hospital

    Zhengzhou, Henan

Other trials in China

About this study

Official title: Compare the Efficacy of Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Graft Surgery

The study population will include all patients undergoing elective CABG. Consent and randomization will occur before surgery. Total 500 patients undergoing elective CABG will be randomly assigned into three groups with 1:1:1 ratio(167 patients per group) in this open-label study. All the enrolled patients will stop oral antiplatelet drugs according to local protocol before the surgery. Within the first 24 hours after surgery, study medication should be restarted and continued for 12 months. Arm A will restart oral antiplatelet drugs by giving aspirin 100mg qd, Arm B will also restart oral antiplatelet drugs by giving ticagrelor 90mg bid plus aspirin 100mg qd and Arm C will also restart oral antiplatelet drugs by giving ticagrelor 90mg bid. Treatment will continue for 12 months, at which time patients will undergo a multislice computed tomography angiography to assess vein graft patency.

This study is designed to show the superiority of ticagrelor and ticagrelor plus aspirin as compared with aspirin monotherapy respectively for the 1-year primary efficacy end point of vein graft patency.

Read the detailed description

The study is designed to show the superiority of ticagrelor and ticagrelor plus aspirin as compared with aspirin monotherapy respectively for the 1-year primary efficacy end point of vein graft patency. The primary comparison includes two separate parts. One is to demonstrate T+A better than A and the other is T better than A.

One year rate of vein graft patency in the aspirin group is estimated as 80%. The assumed rate of ticagrelor plus aspirin is 90%. With a two-sided alpha level 0.05 and 80% power, 199 grafts to each group are required. On the other hand, if we assume the rate of ticagrelor monotherapy has the 1-year vein graft patency rate of 87%, under the same two-sided 0.05 alpha 441 grafts in each arm will offer 80% power to show the superiority of ticagrelor along for the primary efficacy end point.

Combined the above two assumptions, if the allocation rate is 1:1:1, this study needs to recruit 1,323 grafts in total (441 in each) to achieve the pre-specified power for both the two comparisons (T+A vs. A and T vs. A).

The principle investigator assumes that the average number of the vien grafts in one patient is 2.7-3.0. With this assumption, 500 patients are to be recruited, which will provide us a total of 1350 - 1500 grafts.

According to the above, this study will be a confirmatory clinical trial to the primary endpoint.

Being tested
Aspirin, Ticagrelor
Keywords
CABG, Antiplatelet, Ticagrelor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02201771
Study groupRoleWhat they receive
AspirinActive comparatoraspirin 100mg tablet by mouth daily for 12 months
Receives: Drug: Aspirin
Ticagrelor plus AspirinExperimentalticagrelor 90mg tablet by mouth twice daily and aspirin 100mg tablet by mouth daily for 12 months
Receives: Drug: Aspirin; Drug: Ticagrelor
TicagrelorExperimentalticagrelor 90mg tablet by mouth twice daily for 12 months
Receives: Drug: Ticagrelor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Patency of Saphenous Vein Grafts

    assessed by multislice computed tomography angiography (MSCTA) or coronary angiography(CAG). FitzGibbon grade A (stenosis <50%) is defined as "patency".

    Measured: up to 12 months

Secondary outcomes (5)

  1. The Patency of Saphenous Vein Grafts

    assessed by MSCTA or CAG. FitzGibbon grade A (stenosis <50%) is defined as "patency".

    Measured: up to 7 days

  2. The Rate of Post-operative Atrial Fibrillation After CABG.

    Number of Participants with Post-operative Atrial Fibrillation after CABG

    Measured: up to 7 days

  3. The Rate of Freedom From Angina According to Canadian Cardiovascular Society (CCS) Classification

    Number of Participants Free of Angina per CCS Classification

    Measured: up to 12 months

  4. The Number of Major Adverse Cardiovascular Event (MACE)

    MACE, composite of CV death, myocardial infarction or stroke (ischaemic or unknown etiology)

    Measured: up to 12 months

  5. Number of the Major Bleeding Events

    According to modified TIMI criteria, the "Major Bleeding Events" is defined as the combination of CABG-related bleeding and non-CABG-related major bleeding(Intracranial bleeding, Clinically overt signs of hemorrhage with hemoglobin drop ≥5 g/dL and Fatal bleeding).

    Measured: up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionJan 2017
  4. Study completionJan 2017

Resources

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
None (open label)
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02201771
Sponsor's protocol ID
ISSBRIL0211
Acronym
DACAB
Status last verified
Aug 2019
First submitted
24 Jul 2014
Last updated
13 Aug 2019

Publications

  • Zhao Q, Zhu Y, Xu Z, Cheng Z, Mei J, Chen X, Wang X. Effect of Ticagrelor Plus Aspirin, Ticagrelor Alone, or Aspirin Alone on Saphenous Vein Graft Patency 1 Year After Coronary Artery Bypass Grafting: A Randomized Clinical Trial. JAMA. 2018 Apr 24;319(16):1677-1686. doi: 10.1001/jama.2018.3197.

    PubMed 29710164

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aspirin and Ticagrelor in people with Coronary Artery Bypass and Antiplatelet Agents, run by Ruijin Hospital at 6 sites 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 4 inclusion and 23 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 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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?

Yes. Results are posted in the registry (first posted 1 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Patency of Saphenous Vein Grafts (time frame: up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02201771, which also lists 1 linked publication.

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 13 Aug 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in