Effect of Shexiang Tongxin Dropping Pills on Microcirculation in Patients With AMI

NCT04952259 | Unknown Phase 4

• 1 other identifier: M2019480
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a randomized, controlled clinical trial. Evaluation of microcirculation resistance by index of microcirculation resistance to explore the protective effect of Shexiang Tongxin dripping pills on microcirculation in patients with acute anterior myocardial infarction.

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• IMR

  microcirculation resistance index

  detected immediately after percutaneous coronary intervention

Secondary Outcomes (1)

• Myocardial injury markers

  72 hours

Study Arms (2)

Intervention group

EXPERIMENTAL

Shexiang Tongxin dripping pills + routine treatment

Drug: Shexiang Tongxin Dropping Pills + routine treatment

Control group

ACTIVE COMPARATOR

routine treatment

Procedure: routine treatment

Interventions

Shexiang Tongxin Dropping Pills + routine treatment DRUG

oral+percutaneous coronary intervention

Also known as: drugs and surgery

Intervention group

routine treatment PROCEDURE

percutaneous coronary intervention

Also known as: surgery

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old, no gender limit;
• Anterior wall STEMI within 12 hours of onset (diagnostic criteria: ischemic chest pain lasting ≥30min; ST-segment elevation or new left bundle branch block in two or more adjacent leads on the ECG; with or without Elevated myocardial markers), emergency PCI treatment is planned;
• Infarct-related coronary vascular anatomy is suitable for PCI treatment;
• Agree and cooperate to participate in this research, and sign an informed consent form

You may not qualify if:

• Past history of myocardial infarction history;
• The arteries related to infarction have received PCI in the past;
• Past CABG history;
• Killip grade of cardiac function ≥ grade III or cardiogenic shock;
• Systolic blood pressure ≤90mmHg;
• Bradycardia, heart rate \<60 beats/min, or atrioventricular block of degree II or more;
• Allergic to Shexiang Tongxin Dropping Pills
• Past history of asthma or severe COPD;
• Severe liver and kidney dysfunction;
• Participate in other clinical trials within 3 months;
• Pregnancy or breastfeeding.

Sponsors & Collaborators

• Peking University Third Hospital: lead

MeSH Terms

Interventions

Pharmaceutical Preparations; Surgical Procedures, Operative

Study Officials

• Liyun He

  Peking University Third Hospital

  STUDY DIRECTOR

Central Study Contacts

Liyun He

CONTACT

+8613901132937; hly26@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: July 7, 2021
• Study Start: August 1, 2021
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2023
• Last Updated: July 7, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share