Acute Coronary SyndromePhase 4NCT03381755
Low-dose Ticagrelor in Chinese ACS Patients Undergoing PCI
A Phase 4 study testing half-dose ticagrelor and standard-dose ticagrelor in people with Acute Coronary Syndrome, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
Trial summary
Dual Antiplatelet Therapy (DAPT) with aspirin and P2Y12 receptor inhibitor remains a cornerstone in the secondary prevention of coronary artery disease (CAD). Clopidogrel is one of the most commonly used antithrombotic agent that inhibits the platelet P2Y(12) adenosine diphosphate (ADP) receptor. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- half-dose ticagrelor and standard-dose ticagrelor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 14 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- After half-dose ticagrelor (loading dose 90mg, and then 45mg bidpo.) treatment for 3 days, the platelet aggregation is effectively inhibited by light transmission aggregometry method and thromboela-stogram.
- planned to undergo PCI recently
- planned to DAPT for 1 year after PCI
Who cannot join
- taken adenosine diphosphate (ADP) receptor antagonists within 2 weeks
- Platelet count <100g/L;
- A history of bleeding tendency;
- Aspirin, ticagrelor or clopidogrel allergies;
- Severe liver injury.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Thromboela-Stogram
Beijing, Beijing Municipality, 100001
Liu Yang, MM, 86-010-801231171
About this study
Official title: Comparative Effectiveness and Safety Analysis of Low-dose and Standard-dose Ticagrelor in Chinese Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention
Dual Antiplatelet Therapy (DAPT) with aspirin and P2Y12 receptor inhibitor remains a cornerstone in the secondary prevention of coronary artery disease (CAD). Clopidogrel is one of the most commonly used antithrombotic agent that inhibits the platelet P2Y(12) adenosine diphosphate (ADP) receptor.
Ticagrelor is an oral, reversibly-binding, direct-acting P2Y12 receptor antagonist used clinically for the prevention of atherothrombotic events in patients with acute coronary syndromes (ACS). Guideline recommendations on the use of dual antiplatelet therapy have been formulated that ticagrelor 90 mg twice daily plus aspirin in preference to clopidogrel 75mg daily plus aspirin for ACS patients. The previous studies have reported that half-dose ticagrelor had the similar inhibitory effect on platelet aggregation as the standard-dose ticagrelor, which was significantly stronger than that in the clopidogrel group. One-quarter standard-dose ticagrelor provided greater degree of platelet inhibition than standard dose clopidogrel in Chinese patients with stable CAD. But the effectiveness and safety of low-dose ticagrelor remain yet not very clearly in Chinese patients with acute coronary syndrome undergoing percutaneous coronary intervention.
- Conditions
- Acute Coronary Syndrome
- Being tested
- half-dose ticagrelor, standard-dose ticagrelor
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
half-dose ticagrelorDrug
To observe the effectiveness and safety of ticagrelor 45mg bidpo. in Chinese ACS patients undergoing PCI.
standard-dose ticagrelorDrug
To observe the effectiveness and safety of ticagrelor 90mg bidpo. in Chinese ACS patients undergoing PCI.
| Study group | Role | What they receive |
|---|---|---|
| half-dose ticagrelor | Experimental | Not described Receives: Drug: half-dose ticagrelor |
| standard-dose ticagrelor | Active comparator | Not described Receives: Drug: standard-dose ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
thromboela-stogram
inhibition of platelet aggregation (ADP) ; MA (ADP)
Measured: up to 6 months
thromboela-stogram
inhibition of platelet aggregation; MA
Measured: up to 1 year
Secondary outcomes (3)
MACE
cardiovascular death, non-fatal myocardial infarction and stroke
Measured: up to 1 year
Side effects including bleeding and dyspnea
Measured: up to 1 year
The rate of treatment interruption due to ticagrelor intolerance.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study start1 Jan 2018
- Primary completion14 Dec 2019 (estimated)
- Study completion14 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yue Li, PhD, Principal investigator, Cardiovascular Department, the First Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03381755
- Sponsor's protocol ID
- ACS-3
- Status last verified
- Dec 2017
- First submitted
- 14 Dec 2017
- Last updated
- 12 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness and Safety Analysis of Low-dose and Standard-dose Ticagrelor in Chinese Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT03381755
- Acronym / sponsor ID
- ACS-3
- Conditions
- Acute Coronary Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 14 Dec 2019 (estimated)
- Study completion
- 14 Dec 2020 (estimated)
- First posted
- 22 Dec 2017 (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 P2Y12 receptor inhibitor remains a cornerstone in the secondary prevention of coronary artery disease (CAD). Clopidogrel is one of the most commonly used antithrombotic agent that inhibits the platelet P2Y(12) adenosine diphosphate (ADP) receptor.
Ticagrelor is an oral, reversibly-binding, direct-acting P2Y12 receptor antagonist used clinically for the prevention of atherothrombotic events in patients with acute coronary syndromes (ACS). Guideline recommendations on the use of dual antiplatelet therapy have been formulated that ticagrelor 90 mg twice daily plus aspirin in preference to clopidogrel 75mg daily plus aspirin for ACS patients. The previous studies have reported that half-dose ticagrelor had the similar inhibitory effect on platelet aggregation as the standard-dose ticagrelor, which was significantly stronger than that in the clopidogrel group. One-quarter standard-dose ticagrelor provided greater degree of platelet inhibition than standard dose clopidogrel in Chinese patients with stable CAD. But the effectiveness and safety of low-dose ticagrelor remain yet not very clearly in Chinese patients with acute coronary syndrome undergoing percutaneous coronary intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| half-dose ticagrelor | Experimental | Drug: half-dose ticagrelor |
| standard-dose ticagrelor | Active comparator | Drug: standard-dose ticagrelor |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- After half-dose ticagrelor (loading dose 90mg, and then 45mg bidpo.) treatment for 3 days, the platelet aggregation is effectively inhibited by light transmission aggregometry method and thromboela-stogram.
- planned to undergo PCI recently
- planned to DAPT for 1 year after PCI
Key exclusion criteria (5 listed)
- taken adenosine diphosphate (ADP) receptor antagonists within 2 weeks
- Platelet count <100g/L;
- A history of bleeding tendency;
- Aspirin, ticagrelor or clopidogrel allergies;
- Severe liver injury.
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 |
|---|---|---|
| half-dose ticagrelorTo observe the effectiveness and safety of ticagrelor 45mg bidpo. in Chinese ACS patients undergoing PCI. | Drug | half-dose ticagrelor |
| standard-dose ticagrelorTo observe the effectiveness and safety of ticagrelor 90mg bidpo. in Chinese ACS patients undergoing PCI. | Drug | standard-dose ticagrelor |
Primary outcome
thromboela-stogram
Time frame: up to 6 months
inhibition of platelet aggregation (ADP) ; MA (ADP)
thromboela-stogram
Time frame: up to 1 year
inhibition of platelet aggregation; MA
3 secondary outcomes
MACE
Time frame: up to 1 year
Side effects including bleeding and dyspnea
Time frame: up to 1 year
The rate of treatment interruption due to ticagrelor intolerance.
Time frame: up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
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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, PhD principal investigator
Cardiovascular Department, the 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 half-dose ticagrelor and standard-dose ticagrelor in people with Acute Coronary Syndrome, 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 3 inclusion and 5 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 Sep 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guangzhong Liu, PhD (86-451-85555673, lgz2700@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
thromboela-stogram (time frame: up to 6 months). 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 Sep 2018.