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Antiplatelet Effects of Ticagrelor Versus Clopidogrel in American Indian Patients

Information source: Rapid City Regional Hospital, Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Coronary Artery Disease

Intervention: Ticagrelor (Drug); Clopidogrel (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Rapid City Regional Hospital, Inc

Official(s) and/or principal investigator(s):
James S Walder, MD, Principal Investigator, Affiliation: Rapid City Regional Hospital

Summary

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

Clinical Details

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

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

Primary outcome: Compare ticagrelor's versus clopidogrel's inhibition of the P2Y12 receptor as measured by the decrease in P2Y12 Reaction Units (PRU) using VerifyNow TM.

Secondary outcome:

Compare the decrease of P2Y12 Reaction Units (PRU) by VerifyNow TM from ticagrelor and clopidogrel.

Compare the decrease in P2Y l2 Reaction Units (PRU) by VerifyNowâ„¢ from ticagrelor's and clopidogrel's morning dose on Day 7

To evaluate and compare the pharmacodynamic effects, measured by the vasodilator-stimulated phosphoprotein (VASP) assay (platelet reactivity index [PRI]), in all subjects

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

Detailed 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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Regional Heart Doctors/Black Hills Cardiovascular Research, Rapid City, South Dakota 57701, United States
Additional Information

Starting date: December 2012
Last updated: May 4, 2015

Page last updated: August 23, 2015

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