Comparing Ticagrelor Versus Clopidogrel on Microcirculation

NCT02618733 | Completed DMC

• 1 other identifier: 14-218
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• Index of microcirculatory resistance using 0.014-in coronary pressure wire

  6 months

Secondary Outcomes (2)

• Fractional flow reserve using 0.014-in coronary pressure wire

  6 months

• Coronary flow reserve using 0.014-in coronary pressure wire

  6 months

Study Arms (2)

Ticagrelor

EXPERIMENTAL

Ticagrelor 90mg, twice a day

Drug: Ticagrelor

Clopidogrel

ACTIVE COMPARATOR

Clopidogrel 75mg, once a day

Drug: Clopidogrel

Interventions

Ticagrelor DRUG

90mg, twice a day

Ticagrelor

Clopidogrel DRUG

75mg, once a day

Clopidogrel

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dong-A University: lead
• AstraZeneca: collaborator
• Biotronik SE & Co. KG: collaborator

Study Sites (1)

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

Busan, South Korea

Location

Related Publications (3)

• 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.

  PMID: 34656119 DERIVED

• 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.

  PMID: 32028138 DERIVED

• 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.

  PMID: 31554423 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Ticagrelor; Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Kyungil Park, MD

  Dong-A University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: November 25, 2015
• First Posted: December 1, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 31, 2016
• Last Updated: February 5, 2018

Record last verified: 2018-02

Locations

KR (1)