Phase 4 N=36 Randomized Treatment

Ticagrelor China Pharmacokinetic/Pharmacodynamic Study

Stable Coronary Heart Disease (CHD)

Bottom Line

View on ClinicalTrials.gov: NCT02064985 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2016

Primary outcome: Primary: IPA on Day 1 — 27.09; 25.87; 33.34; 57.20 % IPA

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Inhibition of Platelet Aggregation by "Brilinta"(Ticagrelor) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AstraZeneca
Primary completion: Nov 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY IPA on Day 1	27.09; 25.87; 33.34; 57.20; 50.97; 61.64	—
PRIMARY IPA on Day 7	79.69; 89.26; 95.10; 84.70; 89.96; 96.90	—
SECONDARY Percent Change From Baseline in PRU on Day 1	-19.20; -13.76; -19.59; -60.00; -35.25; -67.70	—
SECONDARY Pharmacokinetics Parameters of Ticagrelor on Day 7(1)	616.0; 689.4; 1273	—
SECONDARY Safety---Vital Signs Over Time---Blood Pressure	84.6; 77.1; 74.8; 85.3; 78.2; 74.6	—
SECONDARY Percent Change From Baseline in PRU on Day 7	-77.90; -80.07; -89.33; -79.70; -78.40; -94.10	—
SECONDARY TIPA(Max)---Day 1	3.0; 4.5; 2.5	—
SECONDARY TIPA(Max)---Day 7	1.5; 6.0; 1.3	—
SECONDARY AUEC(Final Extent) on Day 1	2474.4; 2819.4; 3301.0	—
SECONDARY AUEC(Final Extent) on Day 7	1069.9; 1120.1; 1176.9	—
SECONDARY Pharmacokinetics Parameters of Ticagrelor on Day 1(3)	2.00; 3.00; 2.00; 10.07; 9.008; 9.802	—
SECONDARY Pharmacokinetics Parameters of Ticagrelor on Day 1(2)	3220; 3633; 6234; 3102; 3533; 6017	—
SECONDARY Pharmacokinetics Parameters of Ticagrelor on Day 7(2)	2.00; 2.00; 2.00	—
SECONDARY Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(1)	88.28; 77.11; 138.6	—
SECONDARY Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(3)	2.00; 3.00; 3.00; 13.16; 11.64; 11.29	—
SECONDARY Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(1)	143.7; 180.1; 300.6	—
SECONDARY Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(4)	2.00; 2.00; 2.54	—
SECONDARY Pharmacokinetics Parameters of Metabolite : Parent on Day 1--Cmax	0.2277; 0.2146; 0.2005	—
SECONDARY Pharmacokinetics Parameters of Metabolite : Parent on Day 7---Cmax	0.2657; 0.3082; 0.2646	—
SECONDARY Safety---Physical Examination, Summary of Abnormalities	5; 3; 2; 1; 0; 0	—
SECONDARY Safety---Hematology Laboratory Variables Over Time---hematocrit	0.4083; 0.4020; 0.4153	—
SECONDARY Safety---All Allowed Concomitant Medications During Study Treatment	12; 12; 12; 11; 12; 12	—
SECONDARY Safety---Causally Related Adverse Events by System Organ Class and Preferred Term	1; 2; 2; 0; 2; 2	—
SECONDARY Pharmacokinetics Parameters of Ticagrelor on Day 1(1)	464.0; 413.9; 822.1	—
SECONDARY Pharmacokinetics Parameters of Ticagrelor on Day 7(3)	3882; 4351; 8206	—
SECONDARY Pharmacokinetics Parameters of Ticagrelor on Day 7(4)	1.837; 1.882; 2.060	—
SECONDARY Safety---Vital Signs Over Time---Height	166.9; 168.8; 166.5	—
SECONDARY Safety---Vital Signs Over Time---Weight	78.7; 73.8; 73.4	—
SECONDARY Safety---Vital Signs Over Time---Pulse Rate	63.3; 60.5; 59.1; 64.2; 60.6; 61.3	—
SECONDARY Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(2)	921.5; 1108; 1644; 839.6; 906.0; 1534	—
SECONDARY Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(2)	1069; 1314; 2254	—
SECONDARY Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(3)	2.304; 2.606; 2.697	—
SECONDARY Safety---Hematology Laboratory Variables Over Time---Erythrocytes	4.417; 4.409; 4.487	—
SECONDARY Safety---Hematology Laboratory Variables Over Time---Hemoglobin	137.3; 135.4; 138.6	—
SECONDARY Safety---Hematology Laboratory Variables Over Time---Leukocytes	6.64; 6.30; 6.74	—
SECONDARY Safety---Hematology Laboratory Variables Over Time---Platelets	205.3; 186.7; 227.3	—
SECONDARY Safety---Clinical Chemistry Variables Over Time---Glucose	7.48; 7.26; 5.78	—
SECONDARY Safety---Clinical Chemistry Variables Over Time---Alanine Aminotransferase	0.524; 0.429; 0.465	—
SECONDARY Safety---Clinical Chemistry Variables Over Time---Aspartate Aminotransferase	0.497; 0.410; 0.433	—
SECONDARY Safety---Clinical Chemistry Variables Over Time---Alkaline Phosphatase	1.172; 1.027; 1.028	—
SECONDARY Safety---Clinical Chemistry Variables Over Time---Creatinine	81.92; 87.50; 83.50	—
SECONDARY Safety---Clinical Chemistry Variables Over Time---Total Bilirubin	13.98; 14.58; 14.81	—
SECONDARY Safety---Clinical Chemistry Variables Over Time---Sodium	140.7; 140.8; 141.3	—
SECONDARY Safety---Clinical Chemistry Variables Over Time---Potassium	4.41; 4.47; 4.26	—
SECONDARY Safety---Clinical Chemistry Variables Over Time---Chloride	103.2; 103.9; 104.4	—
SECONDARY Safety---Clinical Chemistry Variables Over Time---Phosphate	1.188; 1.154; 1.145	—
SECONDARY Safety---Clinical Chemistry Variables Over Time---Albumin	44.77; 44.68; 46.07	—
SECONDARY Safety---Clinical Chemistry Variables Over Time---Protein	70.2; 69.8; 70.2	—
SECONDARY Safety---Clinical Chemistry Variables Over Time---Blood Urea Nitrogen	5.875; 6.392; 6.108	—
SECONDARY Safety---Clinical Chemistry Variables Over Time---Bicarbonate	28.92; 28.55; 28.15	—
SECONDARY Pharmacokinetics Parameters of Metabolite : Parent on Day 1--AUC(0-inf)	0.3310; 0.3403; 0.3106	—
SECONDARY Pharmacokinetics Parameters of Metabolite : Parent on Day 7---AUC(0-12h)	0.3132; 0.3549; 0.3153	—

Summary

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

Eligibility Criteria

Inclusion Criteria

Provision of signed and dated written informed consent prior to any study specific procedures.
Female or male Chinese (as defined by Chinese Regulatory) patients aged 18 years or older with suitable veins for cannulations or repeated venipunctures.
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.

Female patients without pregnant potential

Exclusion Criteria

Any indication for oral anticoagulant or dual antiplatelet treatment and chronic ASA with doses greater than 100 mg/day.
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.
Increased bleeding risk.
Contraindication or other reason that ASA or ticagrelor should not be administered
Patients that are scheduled for revascularization (eg, PCI, CABG) during the study period

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02064985). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.