Antiplatelet Effects of Ticagrelor Versus Clopidogrel in American Indian Patients

NCT01706510 | Completed Phase 4

• 1 other identifier: ISSBRIL0076
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronary Artery Disease

Keywords

Clopidogrel; Ticagrelor; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Platelet Aggregation Inhibitors; Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Physiological Effects of Drugs

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

• 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

• 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

• Assess and to compare the percentage of subjects with High on-treatment Platelet Reactivity (HPR) at all time points after randomized study treatment.

  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

Other Outcomes (1)

• 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

Study Arms (2)

Ticagrelor

EXPERIMENTAL

Ticagrelor 180 mg loading dose followed by 90 mg bid for 7 days ± 2 days

Drug: Ticagrelor; Drug: Clopidogrel

Clopidogrel

ACTIVE COMPARATOR

Clopidogrel 600 mg Loading Dose followed by 75 mg Daily for 7 days ± 2 days

Drug: Ticagrelor; Drug: Clopidogrel

Interventions

Ticagrelor DRUG

Ticagrelor 180 mg loading dose followed by 90 mg bid for 7 days ± 2 days

Also known as: Brand Name: Brilinta

Clopidogrel; Ticagrelor

Clopidogrel DRUG

Clopidogrel 600 mg loading dose followed by 75 mg Daily for 7 days ± 2 days

Also known as: Brand Name: Plavix

Clopidogrel; Ticagrelor

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rapid City Regional Hospital, Inc: lead
• AstraZeneca: collaborator

Study Sites (1)

Regional Heart Doctors/Black Hills Cardiovascular Research

Rapid City, South Dakota, 57701, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

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

Study Officials

• James S Walder, MD

  Rapid City Regional Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 10, 2012
• First Posted: October 15, 2012
• Study Start: December 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 5, 2015

Record last verified: 2015-05

Locations

US (1)