Acute Coronary SyndromePhase 4TIGERNCT04255602
A Study of Low and Standard-dose Ticagrelor After Intervention for ACS Patients
A Phase 4 study testing Ticagrelor 60mg and Ticagrelor 90mg in people with Acute Coronary Syndrome and Coronary Stent Implantation, run by Shanghai Tong Ren Hospital at 8 sites in China.
Trial summary
This study is to evaluate the safety and efficacy of 60mg ticagrelor plus 100mg Aspirin to prevent major adverse cardiovascular and cerebrovascular events in one years after drug-eluting stents implantation for Chinese ACS patients compared with 90mg ticagrelor plus 100mg Aspirin Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Coronary Syndrome, Coronary Stent Implantation
- What is being tested?
- Ticagrelor 60mg and Ticagrelor 90mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,120 participants
- Where
- 8 sitesChina
- Study dates
- 19 Feb 2020to 31 Dec 2024
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be at least 18 years of age
- Patients should have undergone successful percutaneous coronary intervention with drug-eluting stent for acute coronary syndrome
- Subject understand the study requirements and the treatment procedures and provided informed consent before the procedure
Who cannot join
- Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
- Active bleeding
- Known hypersensitivity or contraindication to study medications
- Non-cardiac co-morbid conditions are present with life expectancy <2 year or that may result in protocol non-compliance (per site investigator's medical judgment).
- Subjects with Cerebral hemorrhage history
- Subjects with stroke history in half a year
- subjects with malignant tumor
- subjects with whom oral anticoagulants are needed
Trial locations and contacts
8 sites in 1 country.
Junbo Ge, Doctor contact
8 sites in 1 country
China8 sites, 8 recruiting
- Not yet recruiting
Yanzhou branch of affiliated hospital of Jining medical university
Jining
Jian Yang
- Recruiting
South East of Shandong hospital
Liaocheng, Shandong
zhongwei Jia, doctor
- Not yet recruiting
zhangshan hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Junbo Ge, Doctor
Junbo Ge, Doctor
- Recruiting
shanghai Tongren hospital
Shanghai, Shanghai Municipality, 200050
Lei Hou, Doctor
Lei Hou, Doctor
- Not yet recruiting
Minhang hospital, Fudan University
Shanghai, Shanghai Municipality, 201100
Wei Hu, Doctor
Wei Hu, Doctor
- Not yet recruiting
Songjiang hospital, Shanghai jiaotong university, school of medicine
Shanghai, Shanghai Municipality
Lei Hou, Dr
- Recruiting
Taishan people's hospital
Taishan, Guangdong, 529200
yan Chen, Doctor
yan chen, Doctor
- Recruiting
Ningbo 4th hospital
Xiangshan, Zhejiang
jianfei Ye, master
About this study
Official title: A Randomized Non-inferiority Study of Low-dose and Standard-dose Ticagrelor After Intervention for Acute Coronary Syndrome
This study is to evaluate the safety and efficacy of 60mg ticagrelor plus 100mg Aspirin to prevent major adverse cardiovascular and cerebrovascular events in one years after drug-eluting stents implantation for Chinese ACS patients compared with 90mg ticagrelor plus 100mg Aspirin
- Being tested
- Ticagrelor 60mg, Ticagrelor 90mg
- 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.
Ticagrelor 60mgDrug
Ticagrelor 60mg plus Aspirin 100mg for experimental group
Ticagrelor 90mgDrug
Ticagrelor 90mg plus Aspirin 100mg for active comparator group
| Study group | Role | What they receive |
|---|---|---|
| low dose ticagrelor | Experimental | After treated with ticagrelor 90mg twice daily and aspirin 100mg once daily for a week,subjects will be treated with ticagrelor 60mg twice daily and aspirin 100mg once daily for until one year after drug eluting stent implantation Receives: Drug: Ticagrelor 60mg |
| standard dose ticagrelor | Active comparator | subjects will be treated with ticagrelor 90mg twice daily and aspirin 100mg once daily for a year since drug eluting stent implantation Receives: Drug: Ticagrelor 90mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
a composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis,coronary revascularization,stroke, and bleeding events of BARC grade ≥2
a composite of death from coronary vascular causes,non-fatal myocardial infarction,stent thrombosis,coronary revascularization, stroke and bleeding type 2, 3 or 5 according to the Bleeding Academic Research Consortium (BARC) criteria
Measured: Stent implantation to 12 months
Secondary outcomes (2)
bleeding events of BARC grade ≥2
bleeding type 2, 3 or 5 according to the Bleeding Academic Research Consortium (BARC) criteria
Measured: Stent implantation to 12 months
a composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis,coronary revascularization,stroke
a composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis,coronary revascularization,stroke
Measured: Stent implantation to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start19 Feb 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Tong Ren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junbo Ge, Doctor, Study chair, Fudan UniversityLei Hou, Doctor, Principal investigator, Shanghai Tong Ren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255602
- Sponsor's protocol ID
- HP2020125
- Acronym
- TIGER
- Status last verified
- Oct 2023
- First submitted
- 29 Jan 2020
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pang Y, Ma M, Xia J, Wang D, YanChen, Ye J, Jia Z, Wu S, Yang J, Hou L. A randomized non-inferiority study of low-dose and standard-dose ticagrelor after intervention for acute coronary syndrome: study protocol for the TIGER STUDY. Trials. 2022 Mar 5;23(1):203. doi: 10.1186/s13063-022-06124-z.
PubMed 35248132
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Non-inferiority Study of Low-dose and Standard-dose Ticagrelor After Intervention for Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT04255602
- Acronym / sponsor ID
- TIGER / HP2020125
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,120 participants (estimated)
- Lead sponsor
- Shanghai Tong Ren HospitalUniversity, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine, Fudan University
- Study start
- 19 Feb 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Feb 2020 (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.
This study is to evaluate the safety and efficacy of 60mg ticagrelor plus 100mg Aspirin to prevent major adverse cardiovascular and cerebrovascular events in one years after drug-eluting stents implantation for Chinese ACS patients compared with 90mg ticagrelor plus 100mg Aspirin
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low dose ticagrelor | Experimental | Drug: Ticagrelor 60mgAfter treated with ticagrelor 90mg twice daily and aspirin 100mg once daily for a week,subjects will be treated with ticagrelor 60mg twice daily and aspirin 100mg once daily for until one year after drug eluting stent implantation |
| standard dose ticagrelor | Active comparator | Drug: Ticagrelor 90mgsubjects will be treated with ticagrelor 90mg twice daily and aspirin 100mg once daily for a year since drug eluting stent implantation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject must be at least 18 years of age
- Patients should have undergone successful percutaneous coronary intervention with drug-eluting stent for acute coronary syndrome
- Subject understand the study requirements and the treatment procedures and provided informed consent before the procedure
Key exclusion criteria (8 listed)
- Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
- Active bleeding
- Known hypersensitivity or contraindication to study medications
- Non-cardiac co-morbid conditions are present with life expectancy <2 year or that may result in protocol non-compliance (per site investigator's medical judgment).
- Subjects with Cerebral hemorrhage history
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 60mgTicagrelor 60mg plus Aspirin 100mg for experimental group | Drug | low dose ticagrelor |
| Ticagrelor 90mgTicagrelor 90mg plus Aspirin 100mg for active comparator group | Drug | standard dose ticagrelor |
Primary outcome
a composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis,coronary revascularization,stroke, and bleeding events of BARC grade ≥2
Time frame: Stent implantation to 12 months
a composite of death from coronary vascular causes,non-fatal myocardial infarction,stent thrombosis,coronary revascularization, stroke and bleeding type 2, 3 or 5 according to the Bleeding Academic Research Consortium (BARC) criteria
2 secondary outcomes
bleeding events of BARC grade ≥2
Time frame: Stent implantation to 12 months
a composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis,coronary revascularization,stroke
Time frame: Stent implantation to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Derived from this study: PubMed 35248132Pang Y, Ma M, Xia J, Wang D, YanChen, Ye J, Jia Z, Wu S, Yang J, Hou L. A randomized non-inferiority study of low-dose and standard-dose ticagrelor after intervention for acute coronary syndrome: study protocol for the TIGER STUDY. Trials. 2022 Mar 5;23(1):203. doi: 10.1186/s13063-022-06124-z.
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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.
Junbo Ge, Doctor contact
Junbo Ge, Doctor study chair
Fudan University
Lei Hou, Doctor principal investigator
Shanghai Tong Ren Hospital
8 sites 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 60mg and Ticagrelor 90mg in people with Acute Coronary Syndrome and Coronary Stent Implantation, run by Shanghai Tong Ren Hospital at 8 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 3 inclusion and 8 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 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Hou, Doctor (13564868096, Dr_houlei@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
a composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis,coronary revascularization,stroke, and bleeding events of BARC grade ≥2 (time frame: Stent implantation 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 NCT04255602, 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 7 Dec 2023.