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A multicenter, single-blind, randomized controlled clinical trial: the influence of salvianolate injection for the myocardial perfusion and prognosis of primary PCI after acute myocardial infarction

A multicenter, single-blind, randomized controlled clinical trial: the influence of salvianolate injection for the myocardial perfusion and prognosis of primary PCI after acute myocardial infarction

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-08000060
Enrollment
Unknown
Registered
2008-02-11
Start date
2008-03-01
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 myocardial infarction

Interventions

B:Start using tirofiban 30 minutes before the operation. Intravenous injection 10ug/kg within 3 minutes, and then continuous intravenous drip 0.15 ug/kg/min for 36 hours
C:Placebo group: routine treatment for emergency PCI after acute myocardial infarction is given. No uses of studied agents mentioned above or intravenous use of TCM and calcium antagonists
A:Start using salvianotlate 30 minutes before the operation (400mg + NS 100ml, 50mL/h), and then continue intravenous use of salvianotlate, Qd.

Sponsors

The 6th people's hospital of Shanghai
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Hospitalized patients of acute myocardial infarction with ST-elevation, confirmed by ECG and myocardial enzyme tests; 2. Patients according with the emergency PCI indications receive primary PCI after signing operation informed consents within 12 hours of disease onset.

Exclusion criteria

Exclusion criteria: 1. No indications for emergency PCI, no consents on operation, or operation failure; 2. Left bundle branch block; 3. Unstable hemodynamics; 4. Having contradictions for salvianotlate or having no agreement of the use of salvianotlate; 5. Having contradictions for antiplatelet agents, including aspirin, ticlopidine, clopidogrel and Tirofiban; 6. Use of tirofiban or salvianotlate within 7 days of inclusion; 7. History of heart failure of myocardial diseases; 8. Severe hepatic or renal dysfunction, serum creatine >220 umol/L for male and >175 umol/L for female; 9. Malignant tumor; 10. Pregnant, post-partum (within 90 days), and breast-feeding females; 11. Inability to complete the study plan such as psychosis diseases and other causes.

Design outcomes

Primary

MeasureTime frame
Myocardial contrast echocardiography;TIMI myocardial perfusion grading (TMPG);Combined endpoints events;TIMI frame count;

Secondary

MeasureTime frame
Left ventricular ejection fraction;Left ventrical remodeling;Wall motion score index;ST fallback of ECG;

Countries

China

Contacts

Public ContactMeng Wei
mrweei@yahoo.com.cn+86 021 64369181-8824

Outcome results

None listed

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