Comparing Ticagrelor Versus Clopidogrel on Microcirculation

NCT ID: NCT02618733

Last Updated: 2018-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-12-31

Brief Summary

Recently, data (PLATO) from an AstraZeneca study of platelet inhibition and patient outcomes, a Phase III pivotal efficacy and safety study with a duration of up to 12 months comparing ticagrelor 90 mg twice daily dosing to clopidogrel 75 mg once daily dosing in acute coronary syndrome patients on ASA background, have demonstrated superiority of ticagrelor over clopidogrel in the prevention of fatal and non-fatal cardiovascular events. Currently, the mechanism for this mortality reduction remain uncertain. One hypothesis is a adenosine mediated theory that ticagrelor has been shown to enhance adenosine-induced vasodilation. Several experimental and clinical studies support the hypothesis that adenosine could reduce cardiac ischaemia reperfusion damage. Moreover, recent study has demonstrated that ticagrelor enhances adenosine-induced coronary vasodilatory responses in healthy humans. However, there are no available data on coronary circulation effects after chronic treatment of ticagrelor in patients with ACS who have altered resting coronary blood flow dynamics due to advanced coronary artery disease.

Detailed Description

This study is a prospective, randomized, open-label, active controlled study with two parallel study groups.

For inclusion in the study subjects should fulfill the following criteria:

1. Provision of informed consent prior to any study specific procedures

2. Female or male aged 20-85 years

3. All patients with ACS scheduled for PCI will be eligible, assuming their ability to understand the character and individual consequences of participation as well as giving written informed consent.

4. Be able to understand and comply with the requirements of the study, as judged by the investigator.

To investigate the effects of ticagrelor on coronary microcirculation, IMR will be measured twice, 6 months apart in the same lesion, compared with clopidogrel.

The IMR is defined as simultaneously measured distal coronary pressure divided by the inverse of the thermodilution-derived hyperaemic mean transit time (Tmn), or more simply, distal coronary pressure multiplied by the Tmn.

Conditions

Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ticagrelor

Ticagrelor 90mg, twice a day

Group Type: EXPERIMENTAL

Ticagrelor

Intervention Type: DRUG

90mg, twice a day

Clopidogrel

Clopidogrel 75mg, once a day

Group Type: ACTIVE_COMPARATOR

Clopidogrel

Intervention Type: DRUG

75mg, once a day

Interventions

Ticagrelor

90mg, twice a day

Intervention Type: DRUG

Clopidogrel

75mg, once a day

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Provision of informed consent prior to any study specific procedures
• All patients with ACS scheduled for PCI will be eligible, assuming their ability to understand the character and individual consequences of participation as well as giving written informed consent.
• Be able to understand and comply with the requirements of the study, as judged by the investigator.

Exclusion Criteria

• History of intracranial bleeding
• Severe hepatic impairment
• Active pathologic bleeding
• Hypersensitivity to ticagrelor or any of the excipients
• Liver cirrhosis greater than or equal to Child class B
• Decreased serum platelet level (≤ 100,000/uL)
• Life expectancy ≤ 1 year
• Need for chronic oral anticoagulant therapy
• Patients with known bleeding diathesis or coagulation disorder
• History of previous intracranial bleed at any time, gastrointestinal bleed within the past 6 months, or major surgery within 30 days.
• Ischemic stroke within the previous 14 days
• Renal failure requiring dialysis or anticipated need for dialysis during the course of the study
• Concern for inability of the patient to comply with study procedures and/or follow up
• Unable to give informed consent.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Biotronik SE & Co. KG

INDUSTRY

Sponsor Role: collaborator

Dong-A University

OTHER

Sponsor Role: lead

Responsible Party

Kyungil Park

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kyungil Park, MD

Role: STUDY_DIRECTOR

Dong-A University

Locations

Department of Internal Medicine,Dong-A University College of Medicine

Busan, , South Korea

Countries

South Korea

References

Moon H, Jo YS, Kim SJ, Jo S, Park K. Comparison of ticagrelor with clopidogrel on quality of life in patients with acute coronary syndrome. Health Qual Life Outcomes. 2021 Oct 16;19(1):242. doi: 10.1186/s12955-021-01875-w.

Reference Type: DERIVED

PMID: 34656119 (View on PubMed)

Jeong YJ, Park K, Kim YD. Comparison between ticagrelor and clopidogrel on myocardial blood flow in patients with acute coronary syndrome, using 13 N-ammonia positron emission tomography. Am Heart J. 2020 Apr;222:121-130. doi: 10.1016/j.ahj.2020.01.013. Epub 2020 Jan 27.

Reference Type: DERIVED

PMID: 32028138 (View on PubMed)

Park K, Cho YR, Park JS, Park TH, Kim MH, Kim YD. Comparison of the Effects of Ticagrelor and Clopidogrel on Microvascular Dysfunction in Patients With Acute Coronary Syndrome Using Invasive Physiologic Indices. Circ Cardiovasc Interv. 2019 Oct;12(10):e008105. doi: 10.1161/CIRCINTERVENTIONS.119.008105. Epub 2019 Sep 26.

Reference Type: DERIVED

PMID: 31554423 (View on PubMed)

Other Identifiers

14-218

Identifier Type: -

Identifier Source: org_study_id