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Coronary Artery Disease | Antiplatelet Effects of Ticagrelor Versus Clopidogrel in American Indian Patients

Coronary Artery Disease research study

What is the primary objective of this study?

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

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Coronary Artery Disease

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:TicagrelorTicagrelor 180 mg loading dose followed by 90 mg bid for 7 days ± 2 days

Drug:ClopidogrelClopidogrel 600 mg loading dose followed by 75 mg Daily for 7 days ± 2 days

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

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

Study Status

Completed

Start Date: December 2012

Completed Date: April 2014

Phase: Phase 4

Type: Interventional

Design:

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.

Study sponsors, principal investigator, and references

Principal Investigator: James S Walder, MD

Lead Sponsor: Rapid City Regional Hospital, Inc

Collaborator: AstraZeneca

More information:https://clinicaltrials.gov/show/NCT01706510

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