Platelet ReactivityPhase 4NCT04001894
Ticagrelor and Clopidogrel on Platelet Effects in Chinese Patients With Stable Coronary Artery Disease
A Phase 4 study testing Ticagrelor 90mg and Clopidogrel 75mg in people with Platelet Reactivity, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
Trial summary
Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor reduces thrombotic events in patients with coronary artery disease, but these benefits come at the expense of increased risk of bleeding when compared with aspirin monotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Platelet Reactivity
- What is being tested?
- Ticagrelor 90mg and Clopidogrel 75mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 2 Jul 2019to 9 Dec 2020
- 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
- Aged ≥18 years
- Subjects had documented with stable CAD
- Women were required to be postmenopausal or surgically sterile
- Patients were required to discontinue clopidogrel or ticagrelor at least 14 days before randomization
- Patients were required to discontinue aspirin at least 14 days before randomization.
Who cannot join
- Acute coronary syndrome
- Planned use of glycoprotein IIb/IIIa receptor inhibitors, adenosine diphosphate (ADP) receptor antagonists other than the study medication, or anticoagulant therapy during the study period
- Platelet count <10×10^4/μL
- Hstory of bleeding tendency
- Diagnosed as respiratory or circulatory instability
- Allergy to ticagrelor or clopidogrel
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ticagrelor and Clopidogrel on Platelet Effects in Chinese Patients With Stable Coronary Artery Disease: a Randomized, Single-blind, Crossover Clinical Study
Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor reduces thrombotic events in patients with coronary artery disease, but these benefits come at the expense of increased risk of bleeding when compared with aspirin monotherapy. Increased evidence showed that P2Y12 inhibitor monotherapy still maintain antiischemic efficacy while reducing the bleeding risk compared with DAPT. Therefore, the investigators performed this study to observe the efficacy of ticagrelor in comparison to clopidogrel in Chinese patients with stable CAD.
Read the detailed description
Ticagrelor is a novel, direct-acting, reversibly binding P2Y12 receptor antagonist. When related with clopidogrel, ticagrelor exhibits a more potent and more predictable antiplatelet effect with a faster onset and offset of action. Current guidelines give a recommendation on the use of dual antiplatelet therapy support ticagrelor 90 mg twice daily over clopidogrel 75 mg daily in addition to aspirin in CAD patients. However, increasing evidence showed ticagrelor increased the risk of bleeding. Recent studies showed that P2Y12 inhibitor monotherapy still maintain antiischemic efficacy while reducing the bleeding risk compared with DAPT. So the investigators performed this randomized, single-blind, crossover clinical trial to observe the effects of standard-dose ticagrelor and standard-dose clopidogrel on platelet reactivity in Chinese patients with stable CAD.
- Conditions
- Platelet Reactivity
- Being tested
- Ticagrelor 90mg, Clopidogrel 75mg
- Keywords
- Ticagrelor, Clopidogrel, Coronary artery disease, platelet function tests
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ticagrelor 90mgDrug
Also called Ticagrelor
Ticagrelor (90.0 mg twice daily) for 2 weeks, followed by a 2-week washout period then 2 weeks crossover phase of clopidogrel (75mg once daily).
Clopidogrel 75mgDrug
Also called Clopidogrel
Clopidogrel (75mg once daily) for 2 weeks, followed by a 2-week washout period then 2 weeks crossover phase of ticagrelor (90.0 mg twice daily).
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor | Experimental | To observe the safety and efficacy of standard-dose ticagrelor in Chinese patients with Stable Coronary Artery Disease Receives: Drug: Ticagrelor 90mg; Drug: Clopidogrel 75mg |
| Clopidogrel | Active comparator | To observe the safety and efficacy of standard-dose clopidogrel in Chinese patients with Stable Coronary Artery Disease Receives: Drug: Ticagrelor 90mg; Drug: Clopidogrel 75mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The platelet inhibition ratio
Thromboelastogram was used to measure platelet inhibition ratio.
Measured: up to 3 months
Secondary outcomes (1)
The platelet aggregation ratio.
Light transmittance aggregometry method was used to measure platelet aggregation ratio.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start2 Jul 2019
- Primary completion9 Dec 2020
- Study completion9 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet ReactivityStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yue LI, First Affiliated Hospital of Harbin Medical University
- Investigators
- Yue Li, Doctor, Principal investigator, First Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001894
- Sponsor's protocol ID
- 20190515
- Status last verified
- Dec 2021
- First submitted
- 26 Jun 2019
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ticagrelor and Clopidogrel on Platelet Effects in Chinese Patients With Stable Coronary Artery Disease: a Randomized, Single-blind, Crossover Clinical Study
- ClinicalTrials.gov ID
- NCT04001894
- Acronym / sponsor ID
- 20190515
- Conditions
- Platelet Reactivity
- Keywords
- Ticagrelor, Clopidogrel, Coronary artery disease, platelet function tests
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Study start
- 2 Jul 2019 (actual)
- Primary completion
- 9 Dec 2020 (actual)
- Study completion
- 9 Dec 2020 (actual)
- First posted
- 28 Jun 2019 (actual)
- 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.
Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor reduces thrombotic events in patients with coronary artery disease, but these benefits come at the expense of increased risk of bleeding when compared with aspirin monotherapy. Increased evidence showed that P2Y12 inhibitor monotherapy still maintain antiischemic efficacy while reducing the bleeding risk compared with DAPT. Therefore, the investigators performed this study to observe the efficacy of ticagrelor in comparison to clopidogrel in Chinese patients with stable CAD.
Detailed description
Ticagrelor is a novel, direct-acting, reversibly binding P2Y12 receptor antagonist. When related with clopidogrel, ticagrelor exhibits a more potent and more predictable antiplatelet effect with a faster onset and offset of action. Current guidelines give a recommendation on the use of dual antiplatelet therapy support ticagrelor 90 mg twice daily over clopidogrel 75 mg daily in addition to aspirin in CAD patients. However, increasing evidence showed ticagrelor increased the risk of bleeding. Recent studies showed that P2Y12 inhibitor monotherapy still maintain antiischemic efficacy while reducing the bleeding risk compared with DAPT. So the investigators performed this randomized, single-blind, crossover clinical trial to observe the effects of standard-dose ticagrelor and standard-dose clopidogrel on platelet reactivity in Chinese patients with stable CAD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor | Experimental | Drug: Ticagrelor 90mg, Drug: Clopidogrel 75mgTo observe the safety and efficacy of standard-dose ticagrelor in Chinese patients with Stable Coronary Artery Disease |
| Clopidogrel | Active comparator | Drug: Ticagrelor 90mg, Drug: Clopidogrel 75mgTo observe the safety and efficacy of standard-dose clopidogrel in Chinese patients with Stable Coronary Artery Disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged ≥18 years
- Subjects had documented with stable CAD
- Women were required to be postmenopausal or surgically sterile
- Patients were required to discontinue clopidogrel or ticagrelor at least 14 days before randomization
- Patients were required to discontinue aspirin at least 14 days before randomization.
Key exclusion criteria (6 listed)
- Acute coronary syndrome
- Planned use of glycoprotein IIb/IIIa receptor inhibitors, adenosine diphosphate (ADP) receptor antagonists other than the study medication, or anticoagulant therapy during the study period
- Platelet count <10×10^4/μL
- Hstory of bleeding tendency
- Diagnosed as respiratory or circulatory instability
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 |
|---|---|---|
| Ticagrelor 90mgAlso: TicagrelorTicagrelor (90.0 mg twice daily) for 2 weeks, followed by a 2-week washout period then 2 weeks crossover phase of clopidogrel (75mg once daily). | Drug | Clopidogrel, Ticagrelor |
| Clopidogrel 75mgAlso: ClopidogrelClopidogrel (75mg once daily) for 2 weeks, followed by a 2-week washout period then 2 weeks crossover phase of ticagrelor (90.0 mg twice daily). | Drug | Clopidogrel, Ticagrelor |
Primary outcome
The platelet inhibition ratio
Time frame: up to 3 months
Thromboelastogram was used to measure platelet inhibition ratio.
1 secondary outcome
The platelet aggregation ratio.
Time frame: up to 3 months
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 11 Jan 2022.
- Individual participant dataSharing planned: No
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Effect of Two Weeks of Low-Dose Apixaban on Platelet Reactivity in Patients With Stable Coronary Artery Disease on Dual Antiplatelet Therapy (Aspirin and Clopidogrel)
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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.
Yue Li, Doctor principal investigator
First Affiliated Hospital of Harbin Medical University
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 90mg and Clopidogrel 75mg in people with Platelet Reactivity, run by First Affiliated Hospital of Harbin Medical University 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 5 inclusion and 6 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 11 Jan 2022. 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?
The platelet inhibition ratio (time frame: up to 3 months). 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 11 Jan 2022.