Stable Coronary Heart Disease (CHD) Clinical Trial
Official title:
An Open Label, Single Centre, Randomised, Phase IV, Pharmacokinetic, Pharmacodynamic, and Safety Study to Evaluate Single and Multiple Doses of 45, 60, and 90 mg of Ticagrelor in Chinese Patients With Stable Coronary Heart Disease
Verified date | November 2014 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
open label, single centre, randomised, Phase IV, pharmacokinetic, pharmacodynamic, and safety study to evaluate single and multiple doses of 45, 60, and 90 mg of ticagrelor in Chinese patients with stable coronary heart disease
Status | Completed |
Enrollment | 61 |
Est. completion date | November 2014 |
Est. primary completion date | November 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Provision of signed and dated written informed consent prior to any study specific procedures. 2. Female or male Chinese (as defined by Chinese Regulatory) patients aged 18 years or older with suitable veins for cannulations or repeated venipunctures. 3. Documented stable coronary heart disease (CHD) fulfilling all of the following, and taking 75-100 mg ASA daily treatment: Diagnosed stable angina pectoris per the guidance of Chinese Society of Cardiology published in 2007, patients with angina severity classified as I and II of Canadian Cardiovascular Society grading of angina pectoris. 4. Female patients without pregnant potential Exclusion Criteria: 1. Any indication for oral anticoagulant or dual antiplatelet treatment and chronic ASA with doses greater than 100 mg/day. 2. Concomitant therapy with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic index, or strong CYP3A inducers within 14 days preceding the first dose of study medication and during study treatment. 3. Increased bleeding risk. 4. Contraindication or other reason that ASA or ticagrelor should not be administered 5. Patients that are scheduled for revascularization (eg, PCI, CABG) during the study period |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Research Site | Beijing |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pharmacodynamic | To determine the Inhibition of Platelet Aggregation (IPA) profiles of single and multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease (CHD) on chronic low dose ASA (75-100mg daily). Primary variable: IPA (final extent) induced by 20µM ADP at each assessment point after single and multiple doses of ticagrelor measured by Light-Transmittance Aggregometry (LTA) |
7 Days | No |
Secondary | Pharmacodynamic | To determine the P2Y12 Reaction Units (PRU) (VerifyNow) profiles of single and multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease on chronic low dose ASA. Secondary variable:Time to peak IPA (TIPAmax) and the area-under-the-effect curve (AUEC) will be estimated for ADP-induced final extent IPA. Inhibition of the P2Y12 receptor at each assessment point after single and multiple doses of ticagrelor as measured by PRU from VerifyNowTM Percent reduction in PRU at each assessment point measured by VerifyNowTM on P2Y12 reaction units , represented as percentage change form baseline (pre-treatment) after single and multiple doses of ticagrelor. |
7days | No |
Secondary | Pharmacokinetics | To determine the PK of ticagrelor and AR-C124910XX (active metabolite). Day 1 PK variables: Cmax, tmax, AUC(0-12h), AUC(0-t), AUC and t1/2 of ticagrelor and AR-C124910XX, metabolite:parent Cmax and AUC ratios. Day 7 PK variables: Cmax, tmax, and AUC(0-12h) of ticagrelor and AR-C124910XX, metabolite:parent Cmax and AUC(0-12h) ratios and accumulation ratio (AR) for ticagrelor and AR-C124910XX. | 7days | No |
Secondary | Safety | To assess the safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: Vital signs (seated blood pressure [BP], pulse) Physical examination Haematology, Clinical Chemistry, and Urinalysis Assessment of adverse events and concomitant medications |
7days | Yes |