Trials / Unknown
UnknownNCT03797729
Early Initiation of Low Dose Tirofiban for PPCI in STEMI Patients.
Early Initiation of Low Dose Tirofiban for Primary Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction.
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- Sponsor
- Shanghai Zhongshan Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
Anti-platelet therapy is a key point of acute myocardial infarction (AMI) treatment. Nowadays, dual anti-platelet therapy based on aspirin and ADP-P2Y12 receptor inhibitor is the preferred treatment before primary percutaneous coronary intervention (PPCI). Restricted by pharmacokinetic and pharmacodynamic characteristics, ADP-P2Y12 receptor inhibitors cannot take effect immediately after oral administration. However, platelet glycoprotein Ⅱb / Ⅲa inhibitors take effect faster. Previous clinical trials indicated that combination of full dose of glycoprotein Ⅱb / Ⅲa inhibitor and dual anti-platelet therapy reduced AMI related ischemia events but increased bleeding events significantly. The high dose of glycoprotein Ⅱb / Ⅲa inhibitor may be the key factor contributing to the increased bleeding events. Therefore, this study aims to evaluate the effectiveness and security of triple anti-platelet therapy based on a small dose of glycoprotein Ⅱb / Ⅲa inhibitor, aspirin and ADP-P2Y12 receptor inhibitor in AMI patients receiving PPCI.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tirofiban | Upon being diagnosed as ST Elevation Myocardial Infarction, if informed consent is obtained, patients start to receive Tirofiban(0.05mg/ml) intravenous drip in a dosage of 4ml/hour (patients weight\<50kg) or 6ml/hour (patients weight \> 50kg) lasting for 24 hours. |
| DRUG | Normal saline | Upon being diagnosed as ST Elevation Myocardial Infarction, if informed consent is obtained, patients start to receive normal saline intravenous drip in a dosage of 4ml/hour (patients weight\<50kg) or 6ml/hour (patients weight \> 50kg) lasting for 24 hours. |
Timeline
- Start date
- 2019-05-14
- Primary completion
- 2021-06-01
- Completion
- 2021-12-01
- First posted
- 2019-01-09
- Last updated
- 2020-01-22
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03797729. Inclusion in this directory is not an endorsement.