Clinical trial NCT05978726: Ticagrelor Versus Clopidogrel for CMD in Patients With AMI: A Retrospective Study Based on the Angio-IMR
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Heart Disease
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 325
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The improvement of angio-IMR
timeFrame: within 24 months post-PCI
Secondary outcomes:
measure: Readmission for heart failure
timeFrame: Within 24 months post-PCI
measure: Myocardial reinfarction
timeFrame: Within 24 months post-PCI
measure: Target vessel revascularization
timeFrame: Within 24 months post-PCI
measure: Non-target vessel revascularization
timeFrame: Within 24 months post-PCI
measure: Cerebral hemorrhage
timeFrame: Within 24 months post-PCI
measure: Other bleeding events
timeFrame: Within 24 months post-PCI
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Second affiliated Hospital Zhejiang University School of Medicine
name: Jun Jiang, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Choi 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.