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

July 31, 2023 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

325

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Second Affiliated Hospital Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within 24 months post-PCI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Readmission for heart failure
Time Frame: Within 24 months post-PCI
Readmission for an acute exacerbation of chronic heart failure or acute heart failure
Within 24 months post-PCI
Myocardial reinfarction
Time Frame: Within 24 months post-PCI
Another myocardial infarction with elevated myocardial enzymes and abnormal electrocardiograms
Within 24 months post-PCI
Target vessel revascularization
Time Frame: Within 24 months post-PCI
Repeat revascularization was performed because of ischemia in the target-vessel territory
Within 24 months post-PCI
Non-target vessel revascularization
Time Frame: Within 24 months post-PCI
Repeat revascularization was performed because of ischemia in the non-target vessel territory
Within 24 months post-PCI
Cerebral hemorrhage
Time Frame: Within 24 months post-PCI
The occurrence of cerebral hemorrhage during the follow-up period was based on imaging CT and MRI
Within 24 months post-PCI
Other bleeding events
Time Frame: Within 24 months post-PCI
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Study Director: Jun Jiang, MD, PhD, Second Affiliated Hospital Zhejiang University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Actual)

May 30, 2020

Study Completion (Actual)

May 30, 2022

Study Registration Dates

First Submitted

July 31, 2023

First Submitted That Met QC Criteria

July 31, 2023

First Posted (Actual)

August 7, 2023

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

July 31, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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