Low-dose Ticagrelor in Chinese ACS Patients Undergoing PCI

Comparative Effectiveness and Safety Analysis of Low-dose and Standard-dose Ticagrelor in Chinese Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03381755

Enrollment

200

Registered

2017-12-22

Start date

2018-01-01

Completion date

2020-12-14

Last updated

2018-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

Brief summary

Dual Antiplatelet Therapy (DAPT) with aspirin and P2Y12 receptor inhibitor remains a cornerstone in the secondary prevention of coronary artery disease (CAD). Clopidogrel is one of the most commonly used antithrombotic agent that inhibits the platelet P2Y(12) adenosine diphosphate (ADP) receptor. Ticagrelor is an oral, reversibly-binding, direct-acting P2Y12 receptor antagonist used clinically for the prevention of atherothrombotic events in patients with acute coronary syndromes (ACS). Guideline recommendations on the use of dual antiplatelet therapy have been formulated that ticagrelor 90 mg twice daily plus aspirin in preference to clopidogrel 75mg daily plus aspirin for ACS patients. The previous studies have reported that half-dose ticagrelor had the similar inhibitory effect on platelet aggregation as the standard-dose ticagrelor, which was significantly stronger than that in the clopidogrel group. One-quarter standard-dose ticagrelor provided greater degree of platelet inhibition than standard dose clopidogrel in Chinese patients with stable CAD. But the effectiveness and safety of low-dose ticagrelor remain yet not very clearly in Chinese patients with acute coronary syndrome undergoing percutaneous coronary intervention.

Interventions

DRUGhalf-dose ticagrelor

To observe the effectiveness and safety of ticagrelor 45mg bidpo. in Chinese ACS patients undergoing PCI.

DRUGstandard-dose ticagrelor

To observe the effectiveness and safety of ticagrelor 90mg bidpo. in Chinese ACS patients undergoing PCI.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* After half-dose ticagrelor (loading dose 90mg, and then 45mg bidpo.) treatment for 3 days, the platelet aggregation is effectively inhibited by light transmission aggregometry method and thromboela-stogram. * planned to undergo PCI recently * planned to DAPT for 1 year after PCI

Exclusion criteria

* taken adenosine diphosphate (ADP) receptor antagonists within 2 weeks * Platelet count \<100g/L; * A history of bleeding tendency; * Aspirin, ticagrelor or clopidogrel allergies; * Severe liver injury.

Design outcomes

Primary

Measure	Time frame	Description
thromboela-stogram	up to 6 months	inhibition of platelet aggregation (ADP) ; MA (ADP)

Secondary

Measure	Time frame	Description
MACE	up to 1 year	cardiovascular death, non-fatal myocardial infarction and stroke
Side effects including bleeding and dyspnea	up to 1 year	—
The rate of treatment interruption due to ticagrelor intolerance.	up to 1 year	—

Countries

China

Contacts

Primary ContactGuangzhong Liu, PhD

lgz2700@126.com86-451-85555673

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026