Antiplatelet Effects of Ticagrelor Versus Clopidogrel in American Indian Patients

Coronary Artery Disease Clinical Trial

Official title:

A Single Center, Randomized, Open Label, Multiple Dose, Crossover Study of the Antiplatelet Effects of Ticagrelor Versus Clopidogrel in American Indian Patients With Stable Coronary Artery Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01706510
• Other study ID #: ISSBRIL0076
• Status: Completed
• Phase: Phase 4
• First received: October 10, 2012
• Last updated: May 4, 2015
• Start date: December 2012
• Est. completion date: April 2014

Study information

• Verified date: May 2015
• Source: Rapid City Regional Hospital, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Assess the pharmacodynamic effect of ticagrelor vs. Clopidogrel in American Indian patients with stable coronary artery disease.

Description:

A Single Center, Randomized, Open Label, Multiple Dose, Crossover Study of the Antiplatelet Effects of Ticagrelor Versus Clopidogrel in American Indian Patients With Stable Coronary Artery Disease

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Documented stable CAD fulfilling any of the following, and taking 81mg ASA daily treatment:

• Females must be post menopausal for at least one year or surgically sterile for at least 6 months and negative urine pregnancy test

• Self-identified as American Indian

• Genetic Inclusion Criteria: must sign the informed consent for genetic and biological sample banking.

Exclusion Criteria:

• Any indication for oral anticoagulant or dual antiplatelet treatment

• Concomitant therapy with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic index, or strong CYP3A inducers within 14 days and during study treatment and during:

• Increased bleeding risk including:

• Diabetic patients with HbAlC > 10% at screening

• Contraindication to clopidogrel, ASA, or ticagrelor - A history of alcohol and/or substance abuse that could interfere with conduct of the trial

• Patients requiring dialysis

• Patients scheduled for revascularization (e.g., PCI, CABG) during the study period

• Any acute or chronic unstable condition in the past 30 days

• Known active or recurrent hepatic disorder

• Patients who had ACS or stent placed within 12 months of screening

• History of Uric Acid nephropathy

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Ticagrelor
Ticagrelor 180 mg loading dose followed by 90 mg bid for 7 days ± 2 days
• Clopidogrel
Clopidogrel 600 mg loading dose followed by 75 mg Daily for 7 days ± 2 days

Locations

Country	Name	City	State
United States	Regional Heart Doctors/Black Hills Cardiovascular Research	Rapid City	South Dakota

Sponsors (2)

Lead Sponsor	Collaborator
Rapid City Regional Hospital, Inc	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	CYP2C19 genotyping to identifying the wild-type CYP2C19 allele (*1), and characterize common alleles known to effect the metabolism of clopidogrel (*2, *3, *4,*5,*6,*7,*8 responsible for poor metabolism and *17 allele responsible for rapid metabolism).		One time-point	No
Primary	Compare ticagrelor's versus clopidogrel's inhibition of the P2Y12 receptor as measured by the decrease in P2Y12 Reaction Units (PRU) using VerifyNow TM.		At 2 hour time point after loading dose	No
Secondary	Compare the decrease of P2Y12 Reaction Units (PRU) by VerifyNow TM from ticagrelor and clopidogrel.		0.5 and 8 hour time points after loading dose	No
Secondary	Compare the decrease in P2Y l2 Reaction Units (PRU) by VerifyNow™ from ticagrelor's and clopidogrel's morning dose on Day 7		At the 2, 8, and 24 hours after the last dose	No
Secondary	To evaluate and compare the pharmacodynamic effects, measured by the vasodilator-stimulated phosphoprotein (VASP) assay (platelet reactivity index [PRI]), in all subjects		Day1: pre-dose, 0.5, 2, and 8 hours post loading dose Day 7: pre-dose, 2 and 8 hours post dose Day 8: 24 hours post final dose	No
Secondary	Assess and to compare the percentage of subjects with High on-treatment Platelet Reactivity (HPR) at all time points after randomized study treatment.	The High on-treatment Platelet Reactivity will be defined in accordance with the following platelet inhibition level cut-off.; > 208 PRU by the VerifyNow P2Y12 assay; > 230 PRU by the VerifyNow P2Y12 assay; > 50% PRI by the VASP assay	Day 1: Pre-dose, 0.5, 2 and 8 hours post loading dose Day 7: pre-dose, 2 and 8 hours post dose Day 8: 24 hours after final dose	No