Acute Coronary Syndrome
Conditions
Brief summary
A multicenter, single arm, open label, Phase IV study to evaluate safety and to describe the incidence of major cardiovascular events of ticagrelor in Chinese patients with acute coronary syndrome
Interventions
DRUGTicagrelor
90mg/tablet, 1 tablet bid
Sponsors
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 130 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Female or male aged at least 18 years 2.Index event of non-ST or ST segment elevation ACS 3.A patient who is considered as ethnic Chinese
Exclusion criteria
* 1\. With coagulation disorder 2.Index event is an acute complication of PCI 3.Patient has planned for an urgent coronary artery bypass graft (CABG) within 7days from the enrolment 4.Oral anticoagulation therapy within 30 days prior to enrolment or cannot be stopped 5.Increased risk of bradycardic events 6. Concomitant oral or intravenous therapy (see examples below) with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic indices, or strong CYP3A inducers 7.Increased risk of bradycardic events (eg, no pacemaker and known sick sinus syndrome, second degree A-V block, third degree A-V block or previous documented syncope suspected to be due to bradycardia unless treated with a pacemaker). 8.Known clinically important thrombocytopenia 9.Known clinically important anaemia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding Events | 12 months | PLATO-defined fatal/life threatening, major, major+minor,major+minor+minimal |
| Serious Adverse Events Other Than Bleeding | 12 months | SAEs except the blending events which have aleady been reported as SAEs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major CV Events | 12 months | Combination of CV death, MI, and stroke |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ticargrelor 90 mg/tablet, 1 tablet bid | 2,001 |
| Total | 2,001 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Other | 1 |
| Overall Study | Severe non-compliance to protocol | 7 |
| Overall Study | Subject decision | 80 |
| Overall Study | Subject Lost to Follow up | 2 |
Baseline characteristics
| Characteristic | Ticargrelor |
|---|---|
| Age, Continuous | 59.3 Years STANDARD_DEVIATION 10.83 |
| Age, Customized < 75 years | 1854 Participants |
| Age, Customized >= 75 years | 147 Participants |
| Race/Ethnicity, Customized Asian | 2001 Participants |
| Race/Ethnicity, Customized Hispanic or latino | 0 Participants |
| Race/Ethnicity, Customized Not hispanic or latino | 2001 Participants |
| Race/Ethnicity, Customized Other | 0 Participants |
| Sex: Female, Male Female | 422 Participants |
| Sex: Female, Male Male | 1579 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 230 / 2,001 |
| serious Total, serious adverse events | 161 / 2,001 |
Outcome results
Primary
Bleeding Events
PLATO-defined fatal/life threatening, major, major+minor,major+minor+minimal
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ticargrelor | Bleeding Events | Major | 27 Participants |
| Ticargrelor | Bleeding Events | Fatal/life threatening | 17 Participants |
| Ticargrelor | Bleeding Events | Major + minor | 93 Participants |
| Ticargrelor | Bleeding Events | Major + minor + minimal | 426 Participants |
Primary
Serious Adverse Events Other Than Bleeding
SAEs except the blending events which have aleady been reported as SAEs.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ticargrelor | Serious Adverse Events Other Than Bleeding | 116 Participants |
Secondary
Major CV Events
Combination of CV death, MI, and stroke
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ticargrelor | Major CV Events | 85 Participants |