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

NCT05978726 | Completed FDA Drug

• 1 other identifier: 2023007
• Study Type: observational
• Target: 325
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Heart Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Readmission for heart failure

  Within 24 months post-PCI

• Myocardial reinfarction

  Within 24 months post-PCI

• Target vessel revascularization

  Within 24 months post-PCI

• Non-target vessel revascularization

  Within 24 months post-PCI

• Cerebral hemorrhage

  Within 24 months post-PCI

Study Arms (2)

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.

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.

Interventions

Dual antiplatelet therapy with aspirin and either ticagrelor or clopidogrel DRUG

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.

ticagrelor maintenance treatment group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• \) prior treatment with any P2Y12 inhibitor;
• \) need for long-term oral anticoagulation therapy;
• \) previous coronary artery bypass grafting (CABG);
• \) chronic renal dysfunction with estimated glomerular filtration rate (eGFR) \<30 mL/ (min·1.73 m2) or on hemodialysis;
• \) liver cirrhosis ≥Child-Pugh B class;
• \) cancer;
• \) adjustment of dual antiplatelet therapy (DAPT) during follow-up;
• \) inadequate coronary angiographic images.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

Related Publications (3)

• 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.

  PMID: 35636354 BACKGROUND

• 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.

  PMID: 34353599 BACKGROUND

• Fang 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.

  PMID: 39222277 DERIVED

MeSH Terms

Conditions

Coronary Disease

Interventions

Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jun Jiang, MD, PhD

  Second affiliated Hospital Zhejiang University School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 7, 2023
• Study Start: July 1, 2017
• Primary Completion: May 30, 2020
• Study Completion: May 30, 2022
• Last Updated: August 7, 2023

Record last verified: 2023-07

Locations

CN (1)