Ticagrelor Versus Clopidogrel for CMD in Patients With AMI: A Retrospective Study Based on the Angio-IMR

Coronary Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05978726
• Other study ID #: 2023007
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: May 30, 2022

Study information

• Verified date: July 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: May 30, 2022
• Est. primary completion date: May 30, 2020
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Drug:
• Dual antiplatelet therapy with aspirin and either ticagrelor or clopidogrel
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.

Locations

Country	Name	City	State
China	Second affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

References & Publications (2)

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. Erratum In: JACC Cardiovasc Interv. 2022 Oct 10;15(19):2001. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The improvement of angio-IMR	Difference between Angio-IMR at follow-up coronary angiography and Angio-IMR after PCI	within 24 months post-PCI
Secondary	Readmission for heart failure	Readmission for an acute exacerbation of chronic heart failure or acute heart failure	Within 24 months post-PCI
Secondary	Myocardial reinfarction	Another myocardial infarction with elevated myocardial enzymes and abnormal electrocardiograms	Within 24 months post-PCI
Secondary	Target vessel revascularization	Repeat revascularization was performed because of ischemia in the target-vessel territory	Within 24 months post-PCI
Secondary	Non-target vessel revascularization	Repeat revascularization was performed because of ischemia in the non-target vessel territory	Within 24 months post-PCI
Secondary	Cerebral hemorrhage	The occurrence of cerebral hemorrhage during the follow-up period was based on imaging CT and MRI	Within 24 months post-PCI
Secondary	Other bleeding events	Bleeding events such as gingival bleeding, skin bleeding, and gastrointestinal bleeding and so on, occurred during the follow-up period	Within 24 months post-PCI