A Pharmacodynamic Study With Ticagrelor in Hispanic Patients

NCT01523366 | Completed Phase 4 Results

• 1 other identifier: D5130L00012
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in Hispanic patients with stable coronary artery disease.

Conditions

Stable Coronary Artery Disease

Keywords

Stable Coronary Artery Disease, CAD

Outcome Measures

Primary Outcomes (1)

• Inhibition of the P2Y12 Receptor as Measured by P2Y12 Reactions Units (PRU) From VerifyNow™ (a Platelet Function Test Developed by Accumetrics) at 2 Hours After Loading Dose

  Participants with low (\<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value

  At 2 hours after the loading dose

Secondary Outcomes (4)

• Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 0.5 and 8 Hours After Loading Dose

  At 0.5 and 8 hours after the loading dose

• Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 2 and 8 Hours on Day 7 After Multiple Doses and at End of Dosing Interval on Day 8

  At 2 hours and 8 hours on Day 7 after multiple doses, and at the end of dosing interval on Day 8

• Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses

  Predose, 0.5, 2, 8 hours from loading dose; 0, 2, 8 and 12 hours from last dose

• AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses

  Predose, 0.5, 2, 8 hours from loading dose; 0, 2, 8 and 12 hours from last dose

Study Arms (2)

Ticagrelor

EXPERIMENTAL

Drug: Ticagrelor

Clopidogrel

ACTIVE COMPARATOR

Drug: Clopidogrel

Interventions

Ticagrelor DRUG

Min - 90mg/Max - 180mg tablets (loading dose)

Ticagrelor

Clopidogrel DRUG

75mg (once daily)/Max - 600mg tablets (loading dose)

Clopidogrel

Eligibility Criteria

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

You may qualify if:

• Provision of signed and dated informed consent before initiation of any study-related procedures
• Male or female patients aged 18 years or older Documented stable CAD fulfilling and taking 75-100mg ASA daily treatment
• Females must be post menopausal or surgically sterile Self-identified as Hispanic

You may not qualify if:

• Any indication for oral anticoagulant (e.g., atrial fibrillation, mitral stenosis or prosthetic heart valve) or dual antiplatelet treatment (e.g., clopidogrel, prasugrel, ASA dose other than 75 to 100 mg daily) during study period
• Patients who had ACS or stent placed within 12 months of screening Patients with a history of moderate or severe hepatic impairment
• Current smokers, including the use of tobacco containing products in the past 1 month of randomization
• Patients requiring dialysis

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (5)

Research Site

Los Angeles, California, United States

Location

Research Site

Hollywood, Florida, United States

Location

Research Site

Jacksonville, Florida, United States

Location

Research Site

Miami, Florida, United States

Location

Research Site

Linden, New Jersey, United States

Location

Related Links

• D5130L00012\_Clinical\_Study\_Protocol\_Redacted
• CSR\_Synopsis

MeSH Terms

Interventions

Ticagrelor; Clopidogrel

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

Limitations and Caveats

Total N for the secondary outcome analysis after multiple doses and for PK measures was not the same for 2 hours, 8 hours and end of dosing. Only the first time point total N can be reported via the form. Row titles indicate N's where they differ.

Results Point of Contact

• Title: Tomas LG Andersson, MD, PhD
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

1-800-236-9933

Study Officials

• Glenn Carlson, MD

  AstraZeneca PharmaceuticalsRoom C3B-718PO Box 15437Wilmington, DE 19850-5437 USA

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2012
• First Posted: February 1, 2012
• Study Start: April 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: August 18, 2014
• Results First Posted: August 5, 2014

Record last verified: 2014-08

Locations

US (5)