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Benefits and Safety of Early Tirofiban in the Treatment of Patients with Acute Coronary Syndrome: a Prospective, Multicenter and Randomized controlled trial

Benefits and Safety of Early Tirofiban in the Treatment of Patients with Acute Coronary Syndrome: a Prospective, Multicenter and Randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-10000809
Enrollment
Unknown
Registered
2010-03-14
Start date
2009-05-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

acute coronary syndrome

Interventions

1:Group one, conservation treatment group, tirofiban was used in the study group whereas it was not in the control group.its use was according to the instruction book.
2:group two, PCI group, for patients with NSTEACS, tirofiban was used in the study group at least 4 hours before operation and for patients with STEMI, tirofiban was used just before PCI, whereas tiro
its use was according to the instruction book.
3:group three, post-PCI group, tirofiban was used after operation in the study group whereas it was not in the control group. its use was according to the instruction book.

Sponsors

Henan Provincial People’Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. patients were older than 18 years; 2. the moderate and high risk non ST-segment elevation acute coronary syndrome (NSTEACS): patients with symptoms lasting at least 10 minutes or occurred on light activity or at rest within the preceding 48 hours were eligible for enrollment if 1 or more of the following criteria were met: new ST-segment depression or transient[<30-minute] elevation of 1 mm or more or the T wave invertion of 3 mm or more in two or more contiguous leads; a level of troponin or creatine kinase MB(at least two consecutive measurement) that was above the upper limit of the normal range; or at least 3 TIMI (Thrombosis in Myocardial Infarction) unstable angina risk criteria positive; 3. ST-segment elevation acute myocardial infarction (STEMI): patients were eligible for enrollment if a level of troponin or creatine kinase MB (at least two consecutive measurement) that was above the upper limit of the normal range and 1 or more of the following criteria were met: the typical symptom (chest pain lasting at least 30 minutes and not relived by sublingual nitroglycerin); new ST-segment elevation of 1 mm or more or left bundle branch block in two or more contiguous leads; pathological Q wave; new dyskinesis of partly ventrical wall or the lost of normal myocardium.

Exclusion criteria

Exclusion criteria: 1. angina secondary to identifiable factors (such as arrythmia, anemia); 2. allergy to asparin or heparin or tirofibn (including heparin induced thrombocytopenia); 3. refractory hypertension (BP>180/110mmHg); 4. a history of stroke or other cerebrovascular disease within half a year; 5. active bleeding within 3 months or high risk of bleeding; 6. CABG surgery within a month, severe trauma or cardiopulmonary resuscitation within half a month, PCI within 6 months; 7. acute pericarditis; 8. disease of retina (hemorrhage or exudate); 9. use of tirofiban within 14 days; 10. concomitant noncardiac life-threatening disease; 11. definite or suspected pregnancy; 12. thrombolysis within the preceding 48 hours; 13. suspected aortic dissection; 14. certain laboratory abnormalities including abnormal counts of platelets(600*10^9/L), the value of ALT was three times above the upper limit of the normal range, the value of serum creatinine was more than 220umol/L,the value of APTT was 1.3 times above the upper limit of the normal range or the value of INR was more than 1.5, the value of hemoglobin was less than 90g/L.

Design outcomes

Primary

MeasureTime frame
MACE;

Secondary

MeasureTime frame
the composite end point of death and myocardial infarction;

Countries

China

Contacts

Public ContactChuanyu GAO
gaocy2000@yahoo.com.cn+86 13937165590

Outcome results

None listed

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