Coronary Heart DiseaseNCT05978726
Ticagrelor Versus Clopidogrel for CMD in Patients With AMI: A Retrospective Study Based on the Angio-IMR
An observational study of Coronary Heart Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Coronary microvascular dysfunction (CMD) is increasingly recognized as an important indicator for long-term prognosis in patients with acute myocardial infarction (AMI). The angiography-derived index of microcirculatory resistance (angio-IMR) is a novel guidewire-free measure for CMD in patients with AMI. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Dual antiplatelet therapy with aspirin and either ticagrelor or clopidogrel
- How many people
- 325 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 30 May 2022
- Phase
- Observational
- 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 85 years
- All sexes
- Adult, Older adult
Study population: We retrospectively enrolled patients who were diagnosed with AMI, including STEMI and NSTEMI, and underwent successful PCI and routine follow-up coronary angiography at the Second Affiliated Hospital of Zhejiang University School of Medicine between June 1, 2017 and May 31, 2020. The diagnosis of AMI was based on current clinical guidelines. All patients were pretreated with oral aspirin 300mg and a loading dose of ticagrelor 180mg or clopidogrel 300mg before PCI. Patients received dual antiplatelet therapy (DAPT) with aspirin 100mg daily and either ticagrelor 90mg twice daily or clopidogrel 75mg once daily for at least 9 months after PCI. Patients were divided into clopidogrel group and ticagrelor group according to the post-PCI antiplatelet maintenance therapy.
Who may be able to join
- Patients who were diagnosed with AMI, including STEMI and NSTEMI, and underwent successful PCI and routine follow-up coronary angiography at the Second Affiliated Hospital of Zhejiang University School of Medicine between June 1, 2017 and May 31, 2020.
Who cannot join
- 1) prior treatment with any P2Y12 inhibitor;
- 2) need for long-term oral anticoagulation therapy;
- 3) previous coronary artery bypass grafting (CABG);
- 4) chronic renal dysfunction with estimated glomerular filtration rate (eGFR) <30 mL/ (min·1.73 m2) or on hemodialysis;
- 5) liver cirrhosis ≥Child-Pugh B class;
- 6) cancer;
- 7) adjustment of dual antiplatelet therapy (DAPT) during follow-up;
- 8) inadequate coronary angiographic images.
Trial locations and contacts
1 site in 1 country.
China1 site
Second affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
About this study
Official title: Ticagrelor Versus Clopidogrel for Coronary Microvascular Dysfunction in Patients With Acute Myocardial Infarction: A Retrospective Study Based on the Angiography-derived Index of Microcirculatory Resistance
Coronary microvascular dysfunction (CMD) is increasingly recognized as an important indicator for long-term prognosis in patients with acute myocardial infarction (AMI). The angiography-derived index of microcirculatory resistance (angio-IMR) is a novel guidewire-free measure for CMD in patients with AMI. Ticagrelor has recently been suggested to have additional benefits on coronary microcirculation beyond its antiplatelet effect. This study was designed to compare the protective effects of ticagrelor and clopidogrel on CMD and prognostic impact in patients with AMI, using the angio-IMR as a novel assessment tool.
- Conditions
- Coronary Heart Disease
- Being tested
- Dual antiplatelet therapy with aspirin and either ticagrelor or clopidogrel
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual antiplatelet therapy with aspirin and either ticagrelor or clopidogrelDrug
Patients with acute myocardial infarction randomly received dual antiplatelet therapy with with aspirin 100mg daily and either ticagrelor 90mg twice daily or clopidogrel 75mg once daily for at least 9 months after PCI as needed.
| Study group | Role | What they receive |
|---|---|---|
| ticagrelor maintenance treatment group | Patients received dual antiplatelet therapy (DAPT) with aspirin 100mg daily and ticagrelor 90mg twice daily for at least 9 months after PCI. Angio-IMR assessment was performed after primary PCI and during routine follow-up coronary angiography. Receives: Drug: Dual antiplatelet therapy with aspirin and either ticagrelor or clopidogrel | |
| clopidogrel maintenance treatment group | Patients received dual antiplatelet therapy (DAPT) with aspirin 100mg daily and clopidogrel 75mg once daily for at least 9 months after PCI. Angio-IMR assessment was performed after primary PCI and during routine follow-up coronary angiography. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The improvement of angio-IMR
Difference between Angio-IMR at follow-up coronary angiography and Angio-IMR after PCI
Measured: within 24 months post-PCI
Secondary outcomes (6)
Readmission for heart failure
Readmission for an acute exacerbation of chronic heart failure or acute heart failure
Measured: Within 24 months post-PCI
Myocardial reinfarction
Another myocardial infarction with elevated myocardial enzymes and abnormal electrocardiograms
Measured: Within 24 months post-PCI
Target vessel revascularization
Repeat revascularization was performed because of ischemia in the target-vessel territory
Measured: Within 24 months post-PCI
Non-target vessel revascularization
Repeat revascularization was performed because of ischemia in the non-target vessel territory
Measured: Within 24 months post-PCI
Cerebral hemorrhage
The occurrence of cerebral hemorrhage during the follow-up period was based on imaging CT and MRI
Measured: Within 24 months post-PCI
Other bleeding events
Bleeding events such as gingival bleeding, skin bleeding, and gastrointestinal bleeding and so on, occurred during the follow-up period
Measured: Within 24 months post-PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start1 Jul 2017
- Primary completion30 May 2020
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Jiang, MD, PhD, Study director, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978726
- Sponsor's protocol ID
- 2023007
- Status last verified
- Jul 2023
- First submitted
- 31 Jul 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jiang J, Li C, Hu Y, Li C, He J, Leng X, Xiang J, Ge J, Wang J. A novel CFD-based computed index of microcirculatory resistance (IMR) derived from coronary angiography to assess coronary microcirculation. Comput Methods Programs Biomed. 2022 Jun;221:106897. doi: 10.1016/j.cmpb.2022.106897. Epub 2022 May 18.
PubMed 35636354Choi KH, Dai N, Li Y, Kim J, Shin D, Lee SH, Joh HS, Kim HK, Jeon KH, Ha SJ, Kim SM, Jang MJ, Park TK, Yang JH, Song YB, Hahn JY, Doh JH, Shin ES, Choi SH, Gwon HC, Lee JM. Functional Coronary Angiography-Derived Index of Microcirculatory Resistance in Patients With ST-Segment Elevation Myocardial Infarction. JACC Cardiovasc Interv. 2021 Aug 9;14(15):1670-1684. doi: 10.1016/j.jcin.2021.05.027.
PubMed 34353599Fang J, Zhang Y, Zheng Y, Chen D, Yidilisi A, Ji R, Xiang J, Zhang X, Jiang J. Comparison of Ticagrelor with Clopidogrel on Coronary Microvascular Dysfunction Following Acute Myocardial Infarction Using Angiography-Derived Index of Microcirculatory Resistance. Cardiovasc Drugs Ther. 2025 Oct;39(5):1097-1111. doi: 10.1007/s10557-024-07619-4. Epub 2024 Sep 2.
PubMed 39222277
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ticagrelor Versus Clopidogrel for Coronary Microvascular Dysfunction in Patients With Acute Myocardial Infarction: A Retrospective Study Based on the Angiography-derived Index of Microcirculatory Resistance
- ClinicalTrials.gov ID
- NCT05978726
- Acronym / sponsor ID
- 2023007
- Conditions
- Coronary Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 7 Aug 2023 (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.
Coronary microvascular dysfunction (CMD) is increasingly recognized as an important indicator for long-term prognosis in patients with acute myocardial infarction (AMI). The angiography-derived index of microcirculatory resistance (angio-IMR) is a novel guidewire-free measure for CMD in patients with AMI. Ticagrelor has recently been suggested to have additional benefits on coronary microcirculation beyond its antiplatelet effect. This study was designed to compare the protective effects of ticagrelor and clopidogrel on CMD and prognostic impact in patients with AMI, using the angio-IMR as a novel assessment tool.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ticagrelor maintenance treatment group | – | Drug: Dual antiplatelet therapy with aspirin and either ticagrelor or clopidogrelPatients received dual antiplatelet therapy (DAPT) with aspirin 100mg daily and ticagrelor 90mg twice daily for at least 9 months after PCI. Angio-IMR assessment was performed after primary PCI and during routine follow-up coronary angiography. |
| clopidogrel maintenance treatment group | – | –Patients received dual antiplatelet therapy (DAPT) with aspirin 100mg daily and clopidogrel 75mg once daily for at least 9 months after PCI. Angio-IMR assessment was performed after primary PCI and during routine follow-up coronary angiography. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- We retrospectively enrolled patients who were diagnosed with AMI, including STEMI and NSTEMI, and underwent successful PCI and routine follow-up coronary angiography at the Second Affiliated Hospital of Zhejiang University School of Medicine between June 1, 2017 and May 31, 2020. The diagnosis of AMI was based on current clinical guidelines. All patients were pretreated with oral aspirin 300mg and a loading dose of ticagrelor 180mg or clopidogrel 300mg before PCI. Patients received dual antiplatelet therapy (DAPT) with aspirin 100mg daily and either ticagrelor 90mg twice daily or clopidogrel 75mg once daily for at least 9 months after PCI. Patients were divided into clopidogrel group and ticagrelor group according to the post-PCI antiplatelet maintenance therapy.
Key inclusion criteria (1 listed)
- Patients who were diagnosed with AMI, including STEMI and NSTEMI, and underwent successful PCI and routine follow-up coronary angiography at the Second Affiliated Hospital of Zhejiang University School of Medicine between June 1, 2017 and May 31, 2020.
Key exclusion criteria (8 listed)
- 1) prior treatment with any P2Y12 inhibitor;
- 2) need for long-term oral anticoagulation therapy;
- 3) previous coronary artery bypass grafting (CABG);
- 4) chronic renal dysfunction with estimated glomerular filtration rate (eGFR) <30 mL/ (min·1.73 m2) or on hemodialysis;
- 5) liver cirrhosis ≥Child-Pugh B class;
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 |
|---|---|---|
| Dual antiplatelet therapy with aspirin and either ticagrelor or clopidogrelPatients with acute myocardial infarction randomly received dual antiplatelet therapy with with aspirin 100mg daily and either ticagrelor 90mg twice daily or clopidogrel 75mg once daily for at least 9 months after PCI as needed. | Drug | ticagrelor maintenance treatment group |
Primary outcome
The improvement of angio-IMR
Time frame: within 24 months post-PCI
Difference between Angio-IMR at follow-up coronary angiography and Angio-IMR after PCI
6 secondary outcomes
Readmission for heart failure
Time frame: Within 24 months post-PCI
Myocardial reinfarction
Time frame: Within 24 months post-PCI
Target vessel revascularization
Time frame: Within 24 months post-PCI
Non-target vessel revascularization
Time frame: Within 24 months post-PCI
Cerebral hemorrhage
Time frame: Within 24 months post-PCI
Other bleeding events
Time frame: Within 24 months post-PCI
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 7 Aug 2023.
- Background: PubMed 35636354Jiang J, Li C, Hu Y, Li C, He J, Leng X, Xiang J, Ge J, Wang J. A novel CFD-based computed index of microcirculatory resistance (IMR) derived from coronary angiography to assess coronary microcirculation. Comput Methods Programs Biomed. 2022 Jun;221:106897. doi: 10.1016/j.cmpb.2022.106897. Epub 2022 May 18.
- Background: PubMed 34353599Choi KH, Dai N, Li Y, Kim J, Shin D, Lee SH, Joh HS, Kim HK, Jeon KH, Ha SJ, Kim SM, Jang MJ, Park TK, Yang JH, Song YB, Hahn JY, Doh JH, Shin ES, Choi SH, Gwon HC, Lee JM. Functional Coronary Angiography-Derived Index of Microcirculatory Resistance in Patients With ST-Segment Elevation Myocardial Infarction. JACC Cardiovasc Interv. 2021 Aug 9;14(15):1670-1684. doi: 10.1016/j.jcin.2021.05.027.
- Derived from this study: PubMed 39222277Fang J, Zhang Y, Zheng Y, Chen D, Yidilisi A, Ji R, Xiang J, Zhang X, Jiang J. Comparison of Ticagrelor with Clopidogrel on Coronary Microvascular Dysfunction Following Acute Myocardial Infarction Using Angiography-Derived Index of Microcirculatory Resistance. Cardiovasc Drugs Ther. 2025 Oct;39(5):1097-1111. doi: 10.1007/s10557-024-07619-4. Epub 2024 Sep 2.
- Individual participant dataSharing planned: Undecided
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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.
Jun Jiang, MD, PhD study director
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 1 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: finished, as of the sponsor's last update on 7 Aug 2023. 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.
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 improvement of angio-IMR (time frame: within 24 months post-PCI). 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 NCT05978726, which also lists 3 linked publications.
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 Aug 2023.