Coronary Heart DiseaseCREATIVENCT01779401
Clopidogrel Response Evaluation and AnTi-Platelet InterVEntion in High Thrombotic Risk PCI Patients
A study testing Clopidogrel 75mg, Clopidogrel 150mg and Aspirin 100mg in people with Coronary Heart Disease, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 2 sites in China.
Trial summary
To identify the high-risk patients who might have in-stent thrombosis after PCI with thromboelastography and to head-to-head compare two intensified antiplatelet therapeutic strategies of double-dosage Clopidogrel and triple antiplatelet therapy with Cilostazol with the standard antiplatelet therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Clopidogrel 75mg, Clopidogrel 150mg and Aspirin 100mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,078 participants
- Where
- 2 sitesChina
- Study dates
- Sep 2012to Sep 2016
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 75, male or non-pregnant female;
- Stable or unstable angina with evidence of myocardial ischemia, or patient with myocardial infarction;
- Coronary angiography reveals stenosis lesions;
- Discovery of ADP induced platelet inhibition rate < 50% and MAADP >47mm via thromboelastography (indicating low responsiveness to Clopidogrel with high risk for stent thrombosis formation);
- Is able to understand the objective of the trial, takes part voluntarily and signs the written informed consent form.
Who cannot join
- Those who have participated in other drug or therapy equipment clinical trials but did not reach the main study endpoint time limit;
- Symptoms of severe heart failure (NYHA Class III and above) or left ventricular ejection fraction < 40% (ultrasound or left ventricle ngiography);
- Pregnant or lactating women;
- severely impaired renal function before surgery: serum creatinine > 2.0mg/dl;
- Impaired liver function before surgery: Serum GPT > 120U/L;
- Bleeding tendency, history of active peptic ulcer, history of cerebral hemorrhage or cavum subarachnoidale bleeding, patients with antiplatelet agent and anticoagulant treatment contraindications and hence are unable to undergo anticoagulant therapy;
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- Patients who are unable to withstand dual antiplatelet therapy due to allergy to Aspirin, Clopidogrel or ticlopidine, heparin, contrast agent, paclitaxel and metals;
- Leucocyte < 3.5 x 109; and/or platelet < 100,000/mm3 or > 750,000/mm3;
- Patient's life expectancy is less than 12 months;
- Patients who plan to undergo coronary artery bypass grafting or other surgery within 1 year;
- Those waiting for heart transplant;
- Patients who are deemed by the researchers to have low compliance and unable to abide by the requirements and complete the study.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Fuwai Cardiovascular Hospital
Beijing, 100037
Fuwai Cardiovascular Hospital
Beijing
About this study
Official title: Investigator Initiated Prospective Study to Investigate the Best Anti-platelet Treatment in High Thrombotic Risk PCI Patients.
To identify the high-risk patients who might have in-stent thrombosis after PCI with thromboelastography and to head-to-head compare two intensified antiplatelet therapeutic strategies of double-dosage Clopidogrel and triple antiplatelet therapy with Cilostazol with the standard antiplatelet therapy.
Read the detailed description
Study population: Age 18 - 75, male or non-pregnant female; stable or unstable angina with evidence of myocardial ischemia, or patient with myocardial infarction; coronary angiography reveals stenosis lesions; discovery of ADP induced platelet inhibition rate < 50% and MAADP > 47mm via thromboelastography (indicating low responsiveness to Clopidogrel with high risk for stent thrombosis formation); is able to understand the objective of the trial, takes part voluntarily and signs the written informed consent form.
- Conditions
- Coronary Heart Disease
- Being tested
- Clopidogrel 75mg, Clopidogrel 150mg, Aspirin 100mg, Cilostazol 100mg
- Keywords
- PCI, platelet function monitoring, Thrombelastography, clopidogrel, cilostazol, in-stent thrombosis
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clopidogrel 75mgDrug
Clopidogrel 150mgDrug
Aspirin 100mgDrug
Cilostazol 100mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel + Aspirit | Active comparator | A Standard antiplatelet therapy control group： Clopidogrel 75mg Qd + Aspirin 100mg Qd Receives: Drug: Clopidogrel 75mg; Drug: Aspirin 100mg |
| Clopidogrel + Aspirin | Active comparator | B Double-dosage Clopidogrel group： Clopidogrel 150mg Qd + Aspirin 100mg Qd Receives: Drug: Clopidogrel 150mg; Drug: Aspirin 100mg |
| Clopidogrel + Aspirin + Cilostazol | Active comparator | C triple antiplatelet therapy group： Cilostazol 100mg Bid + Aspirin 100mg Qd + Clopidogrel 75mg Qd Receives: Drug: Clopidogrel 75mg; Drug: Aspirin 100mg; Drug: Cilostazol 100mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac and cerebrovascular events
MACCE, including cardiac death, myocardial infarction, target vessel revascularization and cerebrovascular events
Measured: within 1.5years of patient enrolled
Secondary outcomes (3)
Secondary endpoint
Occurrence of stent thrombosis
Measured: within 1.5 years of patients enrolled
bleeding
Major bleeding and minor bleeding
Measured: within 1.5 years of patients' enrolled
quality of life of patient
to evaluate with Seattle Angina Scale
Measured: within 1.5 years of patients' enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startSep 2012
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,078 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Municipal Health Bureau, Haemonetics Corporation, Zhejiang Otsuka Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Yi-Da Tang, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Yuejin Yang, PHD, Study chair, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779401
- Sponsor's protocol ID
- 2011-4003-03
- Acronym
- CREATIVE
- Status last verified
- Jul 2017
- First submitted
- 15 Jan 2013
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tang YD, Wang W, Yang M, Zhang K, Chen J, Qiao S, Yan H, Wu Y, Huang X, Xu B, Gao R, Yang Y; CREATIVE Investigators. Randomized Comparisons of Double-Dose Clopidogrel or Adjunctive Cilostazol Versus Standard Dual Antiplatelet in Patients With High Posttreatment Platelet Reactivity: Results of the CREATIVE Trial. Circulation. 2018 May 22;137(21):2231-2245. doi: 10.1161/CIRCULATIONAHA.117.030190. Epub 2018 Feb 2.
PubMed 29420189
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigator Initiated Prospective Study to Investigate the Best Anti-platelet Treatment in High Thrombotic Risk PCI Patients.
- ClinicalTrials.gov ID
- NCT01779401
- Acronym / sponsor ID
- CREATIVE / 2011-4003-03
- Conditions
- Coronary Heart Disease
- Keywords
- PCI, platelet function monitoring, Thrombelastography, clopidogrel, cilostazol, in-stent thrombosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,078 participants (actual)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Collaborators
- Beijing Municipal Health Bureau, Haemonetics Corporation, Zhejiang Otsuka Pharmaceutical Co., Ltd.
- Study start
- Sep 2012
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 30 Jan 2013 (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.
To identify the high-risk patients who might have in-stent thrombosis after PCI with thromboelastography and to head-to-head compare two intensified antiplatelet therapeutic strategies of double-dosage Clopidogrel and triple antiplatelet therapy with Cilostazol with the standard antiplatelet therapy.
Detailed description
Study population: Age 18 - 75, male or non-pregnant female; stable or unstable angina with evidence of myocardial ischemia, or patient with myocardial infarction; coronary angiography reveals stenosis lesions; discovery of ADP induced platelet inhibition rate < 50% and MAADP > 47mm via thromboelastography (indicating low responsiveness to Clopidogrel with high risk for stent thrombosis formation); is able to understand the objective of the trial, takes part voluntarily and signs the written informed consent form.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel + Aspirit | Active comparator | Drug: Clopidogrel 75mg, Drug: Aspirin 100mgA Standard antiplatelet therapy control group： Clopidogrel 75mg Qd + Aspirin 100mg Qd |
| Clopidogrel + Aspirin | Active comparator | Drug: Clopidogrel 150mg, Drug: Aspirin 100mgB Double-dosage Clopidogrel group： Clopidogrel 150mg Qd + Aspirin 100mg Qd |
| Clopidogrel + Aspirin + Cilostazol | Active comparator | Drug: Clopidogrel 75mg, Drug: Aspirin 100mg, Drug: Cilostazol 100mgC triple antiplatelet therapy group： Cilostazol 100mg Bid + Aspirin 100mg Qd + Clopidogrel 75mg Qd |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 - 75, male or non-pregnant female;
- Stable or unstable angina with evidence of myocardial ischemia, or patient with myocardial infarction;
- Coronary angiography reveals stenosis lesions;
- Discovery of ADP induced platelet inhibition rate < 50% and MAADP >47mm via thromboelastography (indicating low responsiveness to Clopidogrel with high risk for stent thrombosis formation);
- Is able to understand the objective of the trial, takes part voluntarily and signs the written informed consent form.
Key exclusion criteria (12 listed)
- Those who have participated in other drug or therapy equipment clinical trials but did not reach the main study endpoint time limit;
- Symptoms of severe heart failure (NYHA Class III and above) or left ventricular ejection fraction < 40% (ultrasound or left ventricle ngiography);
- Pregnant or lactating women;
- severely impaired renal function before surgery: serum creatinine > 2.0mg/dl;
- Impaired liver function before surgery: Serum GPT > 120U/L;
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 |
|---|---|---|
| Clopidogrel 75mg | Drug | Clopidogrel + Aspirin + Cilostazol, Clopidogrel + Aspirit |
| Clopidogrel 150mg | Drug | Clopidogrel + Aspirin |
| Aspirin 100mg | Drug | Clopidogrel + Aspirin, Clopidogrel + Aspirin + Cilostazol, Clopidogrel + Aspirit |
| Cilostazol 100mg | Drug | Clopidogrel + Aspirin + Cilostazol |
Primary outcome
Major adverse cardiac and cerebrovascular events
Time frame: within 1.5years of patient enrolled
MACCE, including cardiac death, myocardial infarction, target vessel revascularization and cerebrovascular events
3 secondary outcomes
Secondary endpoint
Time frame: within 1.5 years of patients enrolled
bleeding
Time frame: within 1.5 years of patients' enrolled
quality of life of patient
Time frame: within 1.5 years of patients' enrolled
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 19 Jul 2017.
- Derived from this study: PubMed 29420189Tang YD, Wang W, Yang M, Zhang K, Chen J, Qiao S, Yan H, Wu Y, Huang X, Xu B, Gao R, Yang Y; CREATIVE Investigators. Randomized Comparisons of Double-Dose Clopidogrel or Adjunctive Cilostazol Versus Standard Dual Antiplatelet in Patients With High Posttreatment Platelet Reactivity: Results of the CREATIVE Trial. Circulation. 2018 May 22;137(21):2231-2245. doi: 10.1161/CIRCULATIONAHA.117.030190. Epub 2018 Feb 2.
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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.
Yuejin Yang, PHD study chair
Chinese Academy of Medical Sciences, Fuwai Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clopidogrel 75mg, Clopidogrel 150mg and Aspirin 100mg in people with Coronary Heart Disease, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 2 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 5 inclusion and 12 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 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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?
Major adverse cardiac and cerebrovascular events (time frame: within 1.5years of patient enrolled). 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 NCT01779401, 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 19 Jul 2017.