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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 31, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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