The Effects of loW Dose tIcagrelor on Platelet Function Testing in Patients With Stable Coronary arTery Disease

NCT04206176 | Completed Phase 1 FDA Drug

• 1 other identifier: CEC1152/06/19
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the effects of low dose ticagrelor on platelet function testing in patients with stable coronary artery disease.

Conditions

Platelet Dysfunction Due to Drugs

Keywords

antiplatelet drugs; clopidogrel; ticagrelor; high on-treatment platelet reactivity; platelet function

Outcome Measures

Primary Outcomes (1)

• Clinical effectiveness and safety of low ticagrelor as compared to standard dose clopidogrel based on platelet reaction units (PRU).

  Platelet Reaction Units of low dose ticagrelor vs. standard dose clopidogrel

  2 weeks

Study Arms (1)

Single group crossover

EXPERIMENTAL

The patients who are on a maintenance dose of clopidogrel 75mg once daily will be transitioned to ticagrelor 45mg twice daily after which they will be tested.

Drug: Ticagrelor

Interventions

Ticagrelor DRUG

Ticagrelor 45mg twice daily per oral administration

Also known as: Low Dose Ticagrelor

Single group crossover

Eligibility Criteria

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

You may qualify if:

• between 18 and 74 years of age,
• have stable coronary artery disease, already on DAPT with aspirin and clopidogrel for at least 6 months,
• not on any physician-prescribed medications or complementary/alternative therapies,

You may not qualify if:

• presence of active internal bleeding or history of bleeding diathesis or clinical findings associated with an increased risk of bleeding,
• history of ischemic or hemorrhagic stroke, transient ischemic attack, intracranial neoplasm, arteriovenous malformation, or aneurysm,
• history of clinical and/or hemodynamic instability,
• within 1 month of placement of a bare-metal stent,
• within 30 days of coronary artery bypass graft surgery or PCI without a stent placed,
• planned coronary revascularization,
• treatment with fibrin-specific fibrinolytic therapy \<24 h or non-fibrin-specific fibrinolytic therapy \<48 h,
• use of an oral anticoagulation agent or international normalized ratio \>1.5,
• body weight \<60 kg,
• age \>75 years,
• hemoglobin \<10 g/dL,
• platelet count \<100×106/μL,
• creatinine \>2 mg/dL,
• hepatic enzymes \>2.5 times the upper limit of normal,
• pregnancy and/or lactation.

Sponsors & Collaborators

• The University of The West Indies: lead

Study Sites (1)

The University of the West Indies

Saint Augustine, North, 000000, Trinidad and Tobago

Location

Related Publications (1)

• Seecheran N, Boodhai B, Maharaj A, Ramdeen A, Debideen N, Ochalal V, Singh R, Seecheran R, Seecheran V, Persad S, Abdullah H, Peram L, Motilal S, Tello-Montoliu A, Schneider D. The Effect of Low-Dose Ticagrelor on Platelet Function Profiles in Patients With Stable Coronary Artery Disease in Trinidad: The TWIST Pilot Study. Cardiol Ther. 2020 Dec;9(2):493-503. doi: 10.1007/s40119-020-00195-2. Epub 2020 Aug 6.

  PMID: 32766961 DERIVED

MeSH Terms

Interventions

Ticagrelor

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single, group crossover from clopidogrel to low dose ticagrelor.

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: December 20, 2019
• Study Start: October 1, 2019
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: May 21, 2020

Record last verified: 2020-05

Locations

TR (1)