Stable Coronary Heart Disease (CHD)Phase 4NCT02064985
Ticagrelor China Pharmacokinetic/Pharmacodynamic Study
A Phase 4 study testing Inhibition of Platelet Aggregation by "Brilinta"(Ticagrelor) in people with Stable Coronary Heart Disease (CHD), run by AstraZeneca at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Coronary Heart Disease (CHD)
- What is being tested?
- Inhibition of Platelet Aggregation by "Brilinta"(Ticagrelor)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteChina
- Study dates
- Feb 2014to Nov 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the detailed description
Up to 36 patients will be randomized in order to ensure 10 patients per treatment are evaluable.Ticagrelor will be supplied as 45 mg, 60mg, and 90mg tablets. Following an 8 hour fast on single dose on Day 1 and Day 7; on multiple doses from Day 3 to Day 6. Prior to the first dose of study drug there will be a screening period of maximum of 19 days. Patients will report to the clinical pharmacology unit (CPU) on Day -2 and will remain confined there until completion of study procedures on Day 7, the patients will be discharged on Day 8. In addition, patients will return to the CPU for a follow up visit 2 to 5 days after the last dose. Each patients participation, including the screening period, will take approximately 33 days.
- Conditions
- Stable Coronary Heart Disease (CHD)
- Being tested
- Inhibition of Platelet Aggregation by "Brilinta"(Ticagrelor)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhibition of Platelet Aggregation by "Brilinta"(Ticagrelor)Drug
Also called "Brilinta"(Ticagrelor)
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).
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor 45mg | Experimental | A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7. Receives: Drug: Inhibition of Platelet Aggregation by "Brilinta"(Ticagrelor) |
| Ticagrelor 60mg | Experimental | A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7. Receives: Drug: Inhibition of Platelet Aggregation by "Brilinta"(Ticagrelor) |
| Ticagrelor 90mg | Experimental | A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7. Receives: Drug: Inhibition of Platelet Aggregation by "Brilinta"(Ticagrelor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
IPA on Day 1
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).
Measured: Baseline and at 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours, 36 hours,48 hours after dose intake on Day 1
IPA on Day 7
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).
Measured: Baseline and at 0 hour, 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours after dose intake on Day 7
Secondary outcomes (50)
Percent Change From Baseline in PRU on Day 1
Percent Change from baseline in Platelet P2Y12 Reaction Units (PRU)(measured by VerifyNow) profiles of multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Measured: Baseline and at 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours, 36 hours,48 hours after dose intake on Day 1
Pharmacokinetics Parameters of Ticagrelor on Day 7(1)
Pharmacokinetics parameters of Ticagrelor on Day 7---Cmax
Measured: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Safety---Vital Signs Over Time---Blood Pressure
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])
Measured: Baseline, Day 1 to Day 7 and 2 to 5 days after last dose
Percent Change From Baseline in PRU on Day 7
Percent Change from baseline in Platelet P2Y12 Reaction Units (PRU)(measured by VerifyNow) profiles of multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Measured: Baseline and at 0 hour, 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours after dose intake on Day 7
TIPA(Max)---Day 1
The time to peak IPA (TIPAmax) was estimated for ADP-induced final extent IPA.
Measured: Day 1
TIPA(Max)---Day 7
The time to peak IPA (TIPAmax) was estimated for ADP-induced final extent IPA.
Measured: Day 7
AUEC(Final Extent) on Day 1
The area-under-the-effect curve (AUEC) was estimated for ADP-induced final extent IPA.
Measured: IPA was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1
AUEC(Final Extent) on Day 7
The area-under-the-effect curve (AUEC) was estimated for ADP-induced final extent IPA.
Measured: IPA was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Pharmacokinetics Parameters of Ticagrelor on Day 1(3)
The pharmacokinetics parameter of ticagrelor on Day 1---tmax and t1/2
Measured: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1
Pharmacokinetics Parameters of Ticagrelor on Day 1(2)
The pharmacokinetics parameters of Ticagrelor on Day 1---AUC(0-inf), AUC(0-12h) and AUC(0-t).
Measured: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1
Pharmacokinetics Parameters of Ticagrelor on Day 7(2)
The pharmacokinetics parameters of ticagrelor on Day 7---tmax
Measured: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(1)
Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 1---Cmax
Measured: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(3)
Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 1: tmax and t1/2
Measured: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(1)
Pharmacokinetics parameters of Metabolite (AR-C124910XX) on Day 7---Cmax
Measured: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(4)
Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 7---tmax
Measured: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Pharmacokinetics Parameters of Metabolite : Parent on Day 1--Cmax
To determine Cmax ratio for the metabolite to that of the parent compound on Day 1
Measured: Day 1
Pharmacokinetics Parameters of Metabolite : Parent on Day 7---Cmax
To determine Cmax ratio of metabolite to that of the parent compound on Day 7
Measured: Day 7
Safety---Physical Examination, Summary of Abnormalities
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
- Physical examination
Measured: 2 to 5 days after last dose
Safety---Hematology Laboratory Variables Over Time---hematocrit
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
- Haematology---hematocrit
Measured: 2 to 5 days after last dose
Safety---All Allowed Concomitant Medications During Study Treatment
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
- Concomitant medications
Measured: All allowed concomitant medications during study treatment(up to 2-5 days after last dose), includes medications that began prior to randomization but were ongoing after randomization.
Safety---Causally Related Adverse Events by System Organ Class and Preferred Term
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
- Assessment of adverse events
Measured: Includes adverse events with an onset date on or after the date of first dose and up to and including the last study visit (up to 2-5 days after last dose).
Pharmacokinetics Parameters of Ticagrelor on Day 1(1)
The pharmacokinetics parameters of Ticagrelor on Day 1---Cmax
Measured: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1
Pharmacokinetics Parameters of Ticagrelor on Day 7(3)
Pharmacokinetics parameters of Ticagrelor on Day 7---AUC(0-12h)
Measured: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Pharmacokinetics Parameters of Ticagrelor on Day 7(4)
Pharmacokinetics parameters of Ticagrelor on Day 7---Accumulation ratio(ratio of Day 7 AUC(0-12h) to Day 1 AUC(0-12h))
Measured: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Safety---Vital Signs Over Time---Height
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
- Vital signs (Height)
Measured: Baseline
Safety---Vital Signs Over Time---Weight
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
- Vital signs (Weight)
Measured: Baseline
Safety---Vital Signs Over Time---Pulse Rate
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
- Vital signs (Pulse Rate)
Measured: Baseline, Day 1 to Day 7 and 2 to 5 days after last dose
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(2)
Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 1---AUC(0-12h), AUC(0-t) and AUC(0-inf)
Measured: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(2)
Pharmacokinetics parameters of Metabolite (AR-C124910XX) on Day 7---AUC(0-12h)
Measured: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(3)
Pharmacokinetics parameters of Metabolite (AR-C124910XX) on Day 7---Accumulation ratio(ratio of Day 7 AUC(0-12h) to Day 1 AUC(0-12h))
Measured: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Safety---Hematology Laboratory Variables Over Time---Erythrocytes
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
- Haematology---Erythrocytes
Measured: 2 to 5 days after last dose
Safety---Hematology Laboratory Variables Over Time---Hemoglobin
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
- Haematology---Hemoglobin
Measured: 2 to 5 days after last dose
Safety---Hematology Laboratory Variables Over Time---Leukocytes
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
- Haematology---Leukocytes
Measured: 2 to 5 days after last dose
Safety---Hematology Laboratory Variables Over Time---Platelets
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
- Haematology---Platelets
Measured: 2 to 5 days after last dose
Safety---Clinical Chemistry Variables Over Time---Glucose
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
- Clinical Chemistry---Glucose
Measured: 2 to 5 days after last dose
Safety---Clinical Chemistry Variables Over Time---Alanine Aminotransferase
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
- Clinical Chemistry---Alanine Aminotransferase
Measured: 2 to 5 days after last dose
Safety---Clinical Chemistry Variables Over Time---Aspartate Aminotransferase
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
- Clinical Chemistry---Aspartate Aminotransferase
Measured: 2 to 5 days after last dose
Safety---Clinical Chemistry Variables Over Time---Alkaline Phosphatase
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
- Clinical Chemistry---Alkaline Phosphatase
Measured: 2 to 5 days after last dose
Safety---Clinical Chemistry Variables Over Time---Creatinine
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
- Clinical Chemistry---Creatinine
Measured: 2 to 5 days after last dose
Safety---Clinical Chemistry Variables Over Time---Total Bilirubin
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
- Clinical Chemistry---Total Bilirubin
Measured: 2 to 5 days after last dose
Safety---Clinical Chemistry Variables Over Time---Sodium
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
- Clinical Chemistry---Sodium
Measured: 2 to 5 days after last dose
Safety---Clinical Chemistry Variables Over Time---Potassium
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
- Clinical Chemistry---Potassium
Measured: 2 to 5 days after last dose
Safety---Clinical Chemistry Variables Over Time---Chloride
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
- Clinical Chemistry---Chloride
Measured: 2 to 5 days after last dose
Safety---Clinical Chemistry Variables Over Time---Phosphate
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
- Clinical Chemistry---Phosphate
Measured: 2 to 5 days after last dose
Safety---Clinical Chemistry Variables Over Time---Albumin
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
- Clinical Chemistry---Albumin
Measured: 2 to 5 days after last dose
Safety---Clinical Chemistry Variables Over Time---Protein
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
- Clinical Chemistry---Protein
Measured: 2 to 5 days after last dose
Safety---Clinical Chemistry Variables Over Time---Blood Urea Nitrogen
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
- Clinical Chemistry---Blood Urea Nitrogen
Measured: 2 to 5 days after last dose
Safety---Clinical Chemistry Variables Over Time---Bicarbonate
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
- Clinical Chemistry---Bicarbonate
Measured: 2 to 5 days after last dose
Pharmacokinetics Parameters of Metabolite : Parent on Day 1--AUC(0-inf)
To determine AUC(0-inf) ratio for the metabolite to that of the parent compound on Day 1
Measured: Day 1
Pharmacokinetics Parameters of Metabolite : Parent on Day 7---AUC(0-12h)
To determine AUC(0-12h) ratio of metabolite to that of the parent compound on Day 7.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stable Coronary Heart Disease (CHD)Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Haiyan Li, PhD, Principal investigator, The 3rd Hospital of Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02064985
- Sponsor's protocol ID
- D5130C00086
- Status last verified
- Mar 2016
- First submitted
- 12 Feb 2014
- Last updated
- 11 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02064985
- Acronym / sponsor ID
- D5130C00086
- Conditions
- Stable Coronary Heart Disease (CHD)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 17 Feb 2014 (estimated)
- Results
- Posted 11 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Up to 36 patients will be randomized in order to ensure 10 patients per treatment are evaluable.Ticagrelor will be supplied as 45 mg, 60mg, and 90mg tablets. Following an 8 hour fast on single dose on Day 1 and Day 7; on multiple doses from Day 3 to Day 6. Prior to the first dose of study drug there will be a screening period of maximum of 19 days. Patients will report to the clinical pharmacology unit (CPU) on Day -2 and will remain confined there until completion of study procedures on Day 7, the patients will be discharged on Day 8. In addition, patients will return to the CPU for a follow up visit 2 to 5 days after the last dose. Each patients participation, including the screening period, will take approximately 33 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor 45mg | Experimental | Drug: Inhibition of Platelet Aggregation by "Brilinta"(Ticagrelor)A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7. |
| Ticagrelor 60mg | Experimental | Drug: Inhibition of Platelet Aggregation by "Brilinta"(Ticagrelor)A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7. |
| Ticagrelor 90mg | Experimental | Drug: Inhibition of Platelet Aggregation by "Brilinta"(Ticagrelor)A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhibition of Platelet Aggregation by "Brilinta"(Ticagrelor)Also: "Brilinta"(Ticagrelor)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). | Drug | Ticagrelor 45mg, Ticagrelor 60mg, Ticagrelor 90mg |
Primary outcome
IPA on Day 1
Time frame: Baseline and at 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours, 36 hours,48 hours after dose intake on Day 1
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).
IPA on Day 7
Time frame: Baseline and at 0 hour, 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours after dose intake on Day 7
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).
50 secondary outcomes
Percent Change From Baseline in PRU on Day 1
Time frame: Baseline and at 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours, 36 hours,48 hours after dose intake on Day 1
Pharmacokinetics Parameters of Ticagrelor on Day 7(1)
Time frame: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Safety---Vital Signs Over Time---Blood Pressure
Time frame: Baseline, Day 1 to Day 7 and 2 to 5 days after last dose
Percent Change From Baseline in PRU on Day 7
Time frame: Baseline and at 0 hour, 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours after dose intake on Day 7
TIPA(Max)---Day 1
Time frame: Day 1
TIPA(Max)---Day 7
Time frame: Day 7
AUEC(Final Extent) on Day 1
Time frame: IPA was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1
AUEC(Final Extent) on Day 7
Time frame: IPA was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Pharmacokinetics Parameters of Ticagrelor on Day 1(3)
Time frame: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1
Pharmacokinetics Parameters of Ticagrelor on Day 1(2)
Time frame: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1
Pharmacokinetics Parameters of Ticagrelor on Day 7(2)
Time frame: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(1)
Time frame: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(3)
Time frame: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(1)
Time frame: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(4)
Time frame: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Pharmacokinetics Parameters of Metabolite : Parent on Day 1--Cmax
Time frame: Day 1
Pharmacokinetics Parameters of Metabolite : Parent on Day 7---Cmax
Time frame: Day 7
Safety---Physical Examination, Summary of Abnormalities
Time frame: 2 to 5 days after last dose
Safety---Hematology Laboratory Variables Over Time---hematocrit
Time frame: 2 to 5 days after last dose
Safety---All Allowed Concomitant Medications During Study Treatment
Time frame: All allowed concomitant medications during study treatment(up to 2-5 days after last dose), includes medications that began prior to randomization but were ongoing after randomization.
Safety---Causally Related Adverse Events by System Organ Class and Preferred Term
Time frame: Includes adverse events with an onset date on or after the date of first dose and up to and including the last study visit (up to 2-5 days after last dose).
Pharmacokinetics Parameters of Ticagrelor on Day 1(1)
Time frame: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1
Pharmacokinetics Parameters of Ticagrelor on Day 7(3)
Time frame: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Pharmacokinetics Parameters of Ticagrelor on Day 7(4)
Time frame: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Safety---Vital Signs Over Time---Height
Time frame: Baseline
Safety---Vital Signs Over Time---Weight
Time frame: Baseline
Safety---Vital Signs Over Time---Pulse Rate
Time frame: Baseline, Day 1 to Day 7 and 2 to 5 days after last dose
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(2)
Time frame: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(2)
Time frame: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(3)
Time frame: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Safety---Hematology Laboratory Variables Over Time---Erythrocytes
Time frame: 2 to 5 days after last dose
Safety---Hematology Laboratory Variables Over Time---Hemoglobin
Time frame: 2 to 5 days after last dose
Safety---Hematology Laboratory Variables Over Time---Leukocytes
Time frame: 2 to 5 days after last dose
Safety---Hematology Laboratory Variables Over Time---Platelets
Time frame: 2 to 5 days after last dose
Safety---Clinical Chemistry Variables Over Time---Glucose
Time frame: 2 to 5 days after last dose
Safety---Clinical Chemistry Variables Over Time---Alanine Aminotransferase
Time frame: 2 to 5 days after last dose
Safety---Clinical Chemistry Variables Over Time---Aspartate Aminotransferase
Time frame: 2 to 5 days after last dose
Safety---Clinical Chemistry Variables Over Time---Alkaline Phosphatase
Time frame: 2 to 5 days after last dose
Safety---Clinical Chemistry Variables Over Time---Creatinine
Time frame: 2 to 5 days after last dose
Safety---Clinical Chemistry Variables Over Time---Total Bilirubin
Time frame: 2 to 5 days after last dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haiyan Li, PhD principal investigator
The 3rd Hospital of Peking University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Inhibition of Platelet Aggregation by "Brilinta"(Ticagrelor) in people with Stable Coronary Heart Disease (CHD), run by AstraZeneca at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IPA on Day 1 (time frame: Baseline and at 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours, 36 hours,48 hours after dose intake on Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2016.