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A randomized, double-blind, placebo-controlled trial to investigate the improvement of shexiang tongxin dropping pills on myocardial perfusion among acute myocardial infact patients

A randomized, double-blind, placebo-controlled trial to investigate the improvement of shexiang tongxin dropping pills on myocardial perfusion among acute myocardial infact patients

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPC-17010823
Enrollment
Unknown
Registered
2017-03-09
Start date
2017-03-09
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 infact

Interventions

Drug :Before PCI operation 4 pill will be given and patients will receive 2 pill each time, 3 time per day for 30 days
Placebo :Before PCI operation 4 placebo pill will be given and patients will receive 2 placebo pill each time, 3 time per day for 30 days

Sponsors

Second Affiliated Hospital of Second Military Medicial University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. aged 18-75 years; 2. persisitant chest pain (at least 30min and not exceed 24 hours); 3. ST segment elevation great than or equal to 0.1 mm on two neighbouring limb leads or great than or equal to 0.2 mm on two neighbouring precordial leads, or new left bundle branch block; 4. serum cTnT levels exceed 99% upper limit of the reference range or CK-MB levels great than or equal to three time of normal value; 5. Agree to receive PCI operation.

Exclusion criteria

Exclusion criteria: 1. SBP less than 80mmHg; 2. TIMI of Culprit vessels reach 3 by PCI operation without the need of intervention; 3. patients receiving CPR and IABP within 1 month; 4. Dignosed myocardial infact within 1 month; 5. severe heart dysfunction with LVEF less than 30%, or NYHA or Killip levels more than 3; 6. suspected aortic dissection and patients receiving CABG operation; 7. history of cerebral hemorrhage and ischemic stroke within 3 months; 8. patients with hypertrophic obstructive cardiomyopathy, moderate or severe aortic stenosis or regurgitation; 9. severe arrhythmia (atrial fibrillation, atrial flutter, ventricular tachycardia, ventricular fibrillation, type II degree II atrioventricular block); 10. QT/QTc interval prolongation(QTc interval more than 450ms),or with a history of leading to the disease (TdP) including heart failure, hypokalemia and familial long QT syndrome, or drugs which could prolong QTc interval; 11. severe infection; 12. moderate to severe anemia (HGB less than 90g/l); 13. pregnant or lactating women; 14. patients receiving operation within 4 weeks or with severe tendency of haemorrhage; 15. anyone who also participate in other trials recently or within 1 month; 16. hypersensitivity to known components of the tested drug; 17. diagnosed with other diseases with poor prognosis (for example metastatic carcinoma) or increasing the risk of serious adverse events; 18. severe advancing diseases with short life span; 19. other conditions which the researchers commit to unfit for such trial.

Design outcomes

Primary

MeasureTime frame
corrected TIMI scores;one-year MACE(Major adverse cardiac events);

Secondary

MeasureTime frame
Recovery of ST segement after PCI operation;serum cTnT and CK-MB peak levels;LVEDV POD1 and 30;LVEF POD1 and 30;serum NT-proBNP POD1 and 30;CFR evaluated by transthoracic echocardiography POD1 and 30;30/90/180 day MACE(Major adverse cardiac events);

Countries

China

Contacts

Public ContactRu DING

Second Affiliated Hospital of Second Military Medicial University

drdr1@163.com+86 021 81885302

Outcome results

None listed

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