Ticagrelor China Pharmacokinetic/Pharmacodynamic Study

April 5, 2016 updated by: AstraZeneca

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
61

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ticagrelor 45mg
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.
Drug: Inhibition of Platelet Aggregation by "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).
Other Names:
  • "Brilinta"(Ticagrelor)
Experimental: Ticagrelor 60mg
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.
Drug: Inhibition of Platelet Aggregation by "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).
Other Names:
  • "Brilinta"(Ticagrelor)
Experimental: Ticagrelor 90mg
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.
Drug: Inhibition of Platelet Aggregation by "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).
Other Names:
  • "Brilinta"(Ticagrelor)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
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
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).
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
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
Pharmacokinetics parameters of Ticagrelor on Day 7---Cmax
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

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])
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
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.
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
The time to peak IPA (TIPAmax) was estimated for ADP-induced final extent IPA.
Day 1
TIPA(Max)---Day 7
Time Frame: Day 7
The time to peak IPA (TIPAmax) was estimated for ADP-induced final extent IPA.
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
The area-under-the-effect curve (AUEC) was estimated for ADP-induced final extent IPA.
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
The area-under-the-effect curve (AUEC) was estimated for ADP-induced final extent IPA.
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
The pharmacokinetics parameter of ticagrelor on Day 1---tmax and t1/2
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
The pharmacokinetics parameters of Ticagrelor on Day 1---AUC(0-inf), AUC(0-12h) and AUC(0-t).
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
The pharmacokinetics parameters of ticagrelor on Day 7---tmax
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 AR-C124910XX (active metabolite) on Day 1---Cmax
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 AR-C124910XX (active metabolite) on Day 1: tmax and t1/2
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---Cmax
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 AR-C124910XX (active metabolite) on Day 7---tmax
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
To determine Cmax ratio for the metabolite to that of the parent compound on Day 1
Day 1
Pharmacokinetics Parameters of Metabolite : Parent on Day 7---Cmax
Time Frame: Day 7
To determine Cmax ratio of metabolite to that of the parent compound on Day 7
Day 7
Safety---Physical Examination, Summary of Abnormalities
Time Frame: 2 to 5 days after last dose

The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.

Safety will be assessed by:

• Physical examination
2 to 5 days after last dose
Safety---Hematology Laboratory Variables Over Time---hematocrit
Time Frame: 2 to 5 days after last dose

The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.

Safety will be assessed by:

• Haematology---hematocrit
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.

The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.

Safety will be assessed by:

• Concomitant medications
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).

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
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
The pharmacokinetics parameters of Ticagrelor on Day 1---Cmax
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---AUC(0-12h)
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
Pharmacokinetics parameters of Ticagrelor on Day 7---Accumulation ratio(ratio of Day 7 AUC(0-12h) to Day 1 AUC(0-12h))
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

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)
Baseline
Safety---Vital Signs Over Time---Weight
Time Frame: Baseline

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)
Baseline
Safety---Vital Signs Over Time---Pulse Rate
Time Frame: Baseline, Day 1 to Day 7 and 2 to 5 days after last dose

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)
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 AR-C124910XX (active metabolite) on Day 1---AUC(0-12h), AUC(0-t) and AUC(0-inf)
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---AUC(0-12h)
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
Pharmacokinetics parameters of Metabolite (AR-C124910XX) on Day 7---Accumulation ratio(ratio of Day 7 AUC(0-12h) to Day 1 AUC(0-12h))
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

The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.

Safety will be assessed by:

• Haematology---Erythrocytes
2 to 5 days after last dose
Safety---Hematology Laboratory Variables Over Time---Hemoglobin
Time Frame: 2 to 5 days after last dose

The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.

Safety will be assessed by:

• Haematology---Hemoglobin
2 to 5 days after last dose
Safety---Hematology Laboratory Variables Over Time---Leukocytes
Time Frame: 2 to 5 days after last dose

The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.

Safety will be assessed by:

• Haematology---Leukocytes
2 to 5 days after last dose
Safety---Hematology Laboratory Variables Over Time---Platelets
Time Frame: 2 to 5 days after last dose

The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.

Safety will be assessed by:

• Haematology---Platelets
2 to 5 days after last dose
Safety---Clinical Chemistry Variables Over Time---Glucose
Time Frame: 2 to 5 days after last dose

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
2 to 5 days after last dose
Safety---Clinical Chemistry Variables Over Time---Alanine Aminotransferase
Time Frame: 2 to 5 days after last dose

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
2 to 5 days after last dose
Safety---Clinical Chemistry Variables Over Time---Aspartate Aminotransferase
Time Frame: 2 to 5 days after last dose

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
2 to 5 days after last dose
Safety---Clinical Chemistry Variables Over Time---Alkaline Phosphatase
Time Frame: 2 to 5 days after last dose

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
2 to 5 days after last dose
Safety---Clinical Chemistry Variables Over Time---Creatinine
Time Frame: 2 to 5 days after last dose

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
2 to 5 days after last dose
Safety---Clinical Chemistry Variables Over Time---Total Bilirubin
Time Frame: 2 to 5 days after last dose

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
2 to 5 days after last dose
Safety---Clinical Chemistry Variables Over Time---Sodium
Time Frame: 2 to 5 days after last dose

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
2 to 5 days after last dose
Safety---Clinical Chemistry Variables Over Time---Potassium
Time Frame: 2 to 5 days after last dose

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
2 to 5 days after last dose
Safety---Clinical Chemistry Variables Over Time---Chloride
Time Frame: 2 to 5 days after last dose

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
2 to 5 days after last dose
Safety---Clinical Chemistry Variables Over Time---Phosphate
Time Frame: 2 to 5 days after last dose

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
2 to 5 days after last dose
Safety---Clinical Chemistry Variables Over Time---Albumin
Time Frame: 2 to 5 days after last dose

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
2 to 5 days after last dose
Safety---Clinical Chemistry Variables Over Time---Protein
Time Frame: 2 to 5 days after last dose

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
2 to 5 days after last dose
Safety---Clinical Chemistry Variables Over Time---Blood Urea Nitrogen
Time Frame: 2 to 5 days after last dose

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
2 to 5 days after last dose
Safety---Clinical Chemistry Variables Over Time---Bicarbonate
Time Frame: 2 to 5 days after last dose

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
2 to 5 days after last dose
Pharmacokinetics Parameters of Metabolite : Parent on Day 1--AUC(0-inf)
Time Frame: Day 1
To determine AUC(0-inf) ratio for the metabolite to that of the parent compound on Day 1
Day 1
Pharmacokinetics Parameters of Metabolite : Parent on Day 7---AUC(0-12h)
Time Frame: Day 7
To determine AUC(0-12h) ratio of metabolite to that of the parent compound on Day 7.
Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Haiyan Li, PhD, The 3rd Hospital of Peking University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D5130C00086

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Clinical Trials on Stable Coronary Heart Disease (CHD)

Clinical Trials on Inhibition of Platelet Aggregation by "Brilinta"(Ticagrelor)

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