Trial Outcomes & Findings for Brilinta Taiwan Post Approval Safety Study (NCT NCT02406248)

NCT ID: NCT02406248

Last Updated: 2018-10-15

Results Overview

Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined fatal/life-threatening bleedings

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 108 participants
• Primary outcome timeframe: during 1year follow up with ticagrelor treatment
• Results posted on: 2018-10-15

Participant Flow

This study was conducted at 13 centres in Taiwan. The first patient was enrolled on 23 April 2015 and the last visit of the last patient took was on 9 February 2017. Informed consent was received for 113 patients

Out of the patients who provided informed consent 95.6 % (n=108) of the patients received study drug. 8 patients provided informed consent but did not fulfill eligibility criteria, out of whom 5 did not receive treatment and 3 received treatment.

Participant milestones

Measure	Single Arm Ticagrelor 90mg twice daily (bd)
Overall Study STARTED	108
Overall Study COMPLETED	99
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Measure	Single Arm Ticagrelor 90mg twice daily (bd)
Overall Study Death	7
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Brilinta Taiwan Post Approval Safety Study

Baseline characteristics by cohort

Measure	Single Arm n=108 Participants Ticagrelor 90mg twice daily (bd)
Age, Continuous	61.7 years STANDARD_DEVIATION 12.12 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	86 Participants n=5 Participants
Race/Ethnicity, Customized Asian	108 Participants n=5 Participants
Race/Ethnicity, Customized Not hispanic or latino	108 Participants n=5 Participants

PRIMARY outcome

Timeframe: during 1year follow up with ticagrelor treatment

Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined fatal/life-threatening bleedings

Outcome measures

Measure	Single Arm n=108 Participants Ticagrelor 90mg twice daily (bd)
Number of Participants With Fatal/Life-threatening Bleedings Fatal/life-threatening bledings	4 Participants

PRIMARY outcome

Timeframe: during 1year follow up with ticagrelor treatment

Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined major bleedings

Outcome measures

Measure	Single Arm n=108 Participants Ticagrelor 90mg twice daily (bd)
Number of Participants With Bleeding Events (Major Bleedings) Major bleedings	7 Participants

PRIMARY outcome

Timeframe: during 1year follow up with ticagrelor treatment

Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined major + minor bleedings

Outcome measures

Measure	Single Arm n=108 Participants Ticagrelor 90mg twice daily (bd)
Number of Participants With Bleeding Events (Major and Minor Bleedings) Major and minor bleedings	20 Participants

PRIMARY outcome

Timeframe: during 1year follow up with ticagrelor treatment

Evaluation of serious adverse events other than bleedings

Outcome measures

Measure	Single Arm n=108 Participants Ticagrelor 90mg twice daily (bd)
Number of Participants With Other Serious Adverse Event (SAEs) Serious adverse events other than bleeding	21 Participants

PRIMARY outcome

Timeframe: during 1year follow up with ticagrelor treatment

Evaluation of major cardiovascular events including cardiovascular death, myocardial infarction or stroke

Outcome measures

Measure	Single Arm n=108 Participants Ticagrelor 90mg twice daily (bd)
Number of Participants With Major Cardiovascular Events Composite of major cardiovascular events	6 Participants

Adverse Events

Single Arm

Serious events: 23 serious events

Other events: 45 other events

Deaths: 7 deaths

Serious adverse events

Measure	Single Arm n=108 participants at risk Ticagrelor 90mg twice daily (bd)
Infections and infestations Pneumonia	3.7% 4/108 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 1year if the participant completed treatment according to the study plan. All-cause mortality is collected during 1 year follow-up, including deaths that occur more than 7 days after last dose.
Infections and infestations Sepsis	0.93% 1/108 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 1year if the participant completed treatment according to the study plan. All-cause mortality is collected during 1 year follow-up, including deaths that occur more than 7 days after last dose.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.93% 1/108 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 1year if the participant completed treatment according to the study plan. All-cause mortality is collected during 1 year follow-up, including deaths that occur more than 7 days after last dose.
Nervous system disorders Haemorrhagic transformation stroke	0.93% 1/108 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 1year if the participant completed treatment according to the study plan. All-cause mortality is collected during 1 year follow-up, including deaths that occur more than 7 days after last dose.
Eye disorders Glaucoma	0.93% 1/108 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 1year if the participant completed treatment according to the study plan. All-cause mortality is collected during 1 year follow-up, including deaths that occur more than 7 days after last dose.
Ear and labyrinth disorders Vertigo	0.93% 1/108 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 1year if the participant completed treatment according to the study plan. All-cause mortality is collected during 1 year follow-up, including deaths that occur more than 7 days after last dose.
Cardiac disorders Angina pectoris	1.9% 2/108 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 1year if the participant completed treatment according to the study plan. All-cause mortality is collected during 1 year follow-up, including deaths that occur more than 7 days after last dose.
Cardiac disorders Acute coronary syndrome	0.93% 1/108 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 1year if the participant completed treatment according to the study plan. All-cause mortality is collected during 1 year follow-up, including deaths that occur more than 7 days after last dose.
Cardiac disorders Acute myocardial infarction	0.93% 1/108 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 1year if the participant completed treatment according to the study plan. All-cause mortality is collected during 1 year follow-up, including deaths that occur more than 7 days after last dose.
Cardiac disorders Cardiogenic shock	0.93% 1/108 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 1year if the participant completed treatment according to the study plan. All-cause mortality is collected during 1 year follow-up, including deaths that occur more than 7 days after last dose.
Cardiac disorders Coronary artery disease	0.93% 1/108 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 1year if the participant completed treatment according to the study plan. All-cause mortality is collected during 1 year follow-up, including deaths that occur more than 7 days after last dose.
Cardiac disorders Pericardial effusion	0.93% 1/108 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 1year if the participant completed treatment according to the study plan. All-cause mortality is collected during 1 year follow-up, including deaths that occur more than 7 days after last dose.
Vascular disorders Lymphorrhoea	0.93% 1/108 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 1year if the participant completed treatment according to the study plan. All-cause mortality is collected during 1 year follow-up, including deaths that occur more than 7 days after last dose.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.93% 1/108 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 1year if the participant completed treatment according to the study plan. All-cause mortality is collected during 1 year follow-up, including deaths that occur more than 7 days after last dose.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.93% 1/108 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 1year if the participant completed treatment according to the study plan. All-cause mortality is collected during 1 year follow-up, including deaths that occur more than 7 days after last dose.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.93% 1/108 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 1year if the participant completed treatment according to the study plan. All-cause mortality is collected during 1 year follow-up, including deaths that occur more than 7 days after last dose.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.93% 1/108 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 1year if the participant completed treatment according to the study plan. All-cause mortality is collected during 1 year follow-up, including deaths that occur more than 7 days after last dose.
Skin and subcutaneous tissue disorders Rash	0.93% 1/108 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 1year if the participant completed treatment according to the study plan. All-cause mortality is collected during 1 year follow-up, including deaths that occur more than 7 days after last dose.
General disorders Catheter site haematoma	0.93% 1/108 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 1year if the participant completed treatment according to the study plan. All-cause mortality is collected during 1 year follow-up, including deaths that occur more than 7 days after last dose.
General disorders Death	0.93% 1/108 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 1year if the participant completed treatment according to the study plan. All-cause mortality is collected during 1 year follow-up, including deaths that occur more than 7 days after last dose.
General disorders Pyrexia	0.93% 1/108 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 1year if the participant completed treatment according to the study plan. All-cause mortality is collected during 1 year follow-up, including deaths that occur more than 7 days after last dose.
General disorders Sudden death	0.93% 1/108 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 1year if the participant completed treatment according to the study plan. All-cause mortality is collected during 1 year follow-up, including deaths that occur more than 7 days after last dose.
General disorders Vascular stent restenosis	0.93% 1/108 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 1year if the participant completed treatment according to the study plan. All-cause mortality is collected during 1 year follow-up, including deaths that occur more than 7 days after last dose.
Injury, poisoning and procedural complications Procedural haemorrhage	0.93% 1/108 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 1year if the participant completed treatment according to the study plan. All-cause mortality is collected during 1 year follow-up, including deaths that occur more than 7 days after last dose.
Injury, poisoning and procedural complications Subdural haemorrhage	0.93% 1/108 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 1year if the participant completed treatment according to the study plan. All-cause mortality is collected during 1 year follow-up, including deaths that occur more than 7 days after last dose.
Injury, poisoning and procedural complications Tendon injury	0.93% 1/108 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 1year if the participant completed treatment according to the study plan. All-cause mortality is collected during 1 year follow-up, including deaths that occur more than 7 days after last dose.

Other adverse events

Measure	Single Arm n=108 participants at risk Ticagrelor 90mg twice daily (bd)
Cardiac disorders Angina pectoris	5.6% 6/108 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 1year if the participant completed treatment according to the study plan. All-cause mortality is collected during 1 year follow-up, including deaths that occur more than 7 days after last dose.
Injury, poisoning and procedural complications Contusion	6.5% 7/108 • Number of events 12 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 1year if the participant completed treatment according to the study plan. All-cause mortality is collected during 1 year follow-up, including deaths that occur more than 7 days after last dose.
Respiratory, thoracic and mediastinal disorders Cough	9.3% 10/108 • Number of events 11 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 1year if the participant completed treatment according to the study plan. All-cause mortality is collected during 1 year follow-up, including deaths that occur more than 7 days after last dose.
Gastrointestinal disorders Diarrhoea	5.6% 6/108 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 1year if the participant completed treatment according to the study plan. All-cause mortality is collected during 1 year follow-up, including deaths that occur more than 7 days after last dose.
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.3% 10/108 • Number of events 12 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 1year if the participant completed treatment according to the study plan. All-cause mortality is collected during 1 year follow-up, including deaths that occur more than 7 days after last dose.
Skin and subcutaneous tissue disorders Ecchymosis	9.3% 10/108 • Number of events 14 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 1year if the participant completed treatment according to the study plan. All-cause mortality is collected during 1 year follow-up, including deaths that occur more than 7 days after last dose.
Metabolism and nutrition disorders Hyperuricaemia	5.6% 6/108 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 1year if the participant completed treatment according to the study plan. All-cause mortality is collected during 1 year follow-up, including deaths that occur more than 7 days after last dose.
Metabolism and nutrition disorders Hypokalaemia	7.4% 8/108 • Number of events 8 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 1year if the participant completed treatment according to the study plan. All-cause mortality is collected during 1 year follow-up, including deaths that occur more than 7 days after last dose.
General disorders Pyrexia	5.6% 6/108 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 1year if the participant completed treatment according to the study plan. All-cause mortality is collected during 1 year follow-up, including deaths that occur more than 7 days after last dose.
Infections and infestations Urinary tract infection	5.6% 6/108 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 1year if the participant completed treatment according to the study plan. All-cause mortality is collected during 1 year follow-up, including deaths that occur more than 7 days after last dose.

Additional Information

Brilinta Global Clinical Lead

AstraZeneca R&D

Phone: +46 31 776 10 00

Email: kontakt@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place