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Effect of low-dose versus standard-dose Ticagrelor platelet inhibition in medically managed Chinese patients with ACS: an investigator-initialized, prospective, single-center, open-label, parallel-group randomized controlled trial

Effect of low-dose versus standard-dose Ticagrelor platelet inhibition in medically managed Chinese patients with ACS: an investigator-initialized, prospective, single-center, open-label, parallel-group randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024834
Enrollment
Unknown
Registered
2019-07-29
Start date
2019-07-30
Completion date
Unknown
Last updated
2019-08-27

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

Conditions

acqute coronary syndrome

Interventions

Single antiplatelet:Aspirin, 75-150mmg, Q.D.
Low dose ticagrelor group:Aspirin, 75-150mmg, Q.D., combined with Ticagrelor, 60mg, B.I.D.
Clopidogrel group:Aspirin, 75-150mmg, Q.D., combined with Clopidogrel, 50-75mg, Q.D.

Sponsors

Fuwai Central China Cardiovascular Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. high-risk Chinese patients receiving PCI (DAPT score >= 2), aged 18-75 years, gender no limitation; 2. voluntary signing of informed consent; 3. Willing and able to receive 1 year follow-up.

Exclusion criteria

Exclusion criteria: 1. Allergic to aspirin and tegrillo; 2. Uncontrolled hypertension (> 180/110mmhg); 3. STEMI48 hours; 4. Patients with active bleeding within 3 months prior to enrollment and known bleeding tendency or coagulation disorder; 5. The increased risk of bleeding was defined as: (1) A history of intracranial bleeding at any time; (2) Central nervous system tumor or intracranial vascular abnormality (such as aneurysm arteriovenous malformation) at any time; (3) Intracranial or spinal surgery or (4) Gastrointestinal bleeding within the past 6 months or major surgery within the last 30 days. 6. The researchers believe that there are diseases that may affect the normal conduct of the study or that do not cooperate well with the study or patients with significant risk factors such as alcohol or drug abusers with severe cancers of the liver, kidneys, lungs, endocrine systems (such as uncontrolled diabetes or thyroid disease) and neurological or blood system diseases. 7. Known or suspected pregnancy (baseline ss-hcg pregnancy test must be performed for women in reproductive stage); 8. Combined application of strong inducer or inhibitor of CYP P450 3A4, such as remifon; 9. Suspected aortic dissection; 10. Use of anticoagulant drugs during the study period; 11. Completely normal coronary variant angina pectoris; 12. Participated in a clinical study of another drug within 30 days; 13. Previous history of ischemic stroke; 14. Coronary artery bypass grafting has been performed in the past 5 years; 15. There are serious clinical laboratory abnormalities including: (1) Abnormal platelet count ( 600*10^9/L); (2) Three times the normal upper limit of ALT; (3) Blood creatinine > 220 micron /L; (4) Activated partial prothrombin time >1.3 times normal upper limit or INR > 1.5.

Design outcomes

Primary

MeasureTime frame
cTnI/T;CK-MB;CK;BNP;ALT;hemoglobin;platelet;Erythrocyte count;

Countries

China

Contacts

Public ContactMuwei Li

Fuwai Central China Cardiovascular Hospital

limuwei@163.com+86 13838083966

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026