NCT04814121

Brief Summary

Microvascular obstruction is the severe complication of percutaneous coronary intervention (PCI) in patients with acute coronary syndrome. Microvascular obstruction after PCI is often association with poor prognosis. Current treatments do not show improvement in prognosis of microvascular obstruction. Suxiao Jiuxin Pills (SXJX) was shown associated with a reduction in MACE, and an improvement of heart function and quality of life in acute coronary syndrome (ACS) patients with early PCI. To evaluate the effectiveness and safety of SXJX in microvascular obstruction after PCI, the investigators designed this study.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
198

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2021

Typical duration for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

March 24, 2021

Status Verified

March 1, 2021

Enrollment Period

2.4 years

First QC Date

February 25, 2021

Last Update Submit

March 22, 2021

Conditions

Acute Coronary Syndrome

Keywords

Microvascular obstructionAcute Coronary SyndromePercutaneous coronary interventionSuxiao Jiuxin Pills

Outcome Measures

Primary Outcomes (2)

  • Change from baseline myocardial infarct size at 6 months

    MI size measure by CMR

    3-5 days after PCI and 180±7 days

  • Change from baseline incidence of microvascular obstruction at 6 months

    Incidence of Microvascular obstruction measure by CMR

    3-5 days after PCI and 180±7 days

Secondary Outcomes (15)

  • Change from baseline incidence of intramyocardial hemorrhagex at 6 months

    3-5 days after PCI and 180±7 days

  • Change from baseline incidence of area-at-risk at 6 months

    3-5 days after PCI and 180±7 days

  • Change of ST segment in electrocardiogram

    Baseline, immediately after PCI, 5-7 days after PCI, 30±7 days and 180±7 days

  • Change of CK-MB

    Baseline, immediately after PCI, 5-7 days after PCI, and 180±7 days

  • Change of cTnI

    Baseline, immediately after PCI, 5-7 days after PCI, and 180±7 days

  • +10 more secondary outcomes

Study Arms (2)

Suxiao Jiuxin Pills

EXPERIMENTAL

Suxiao Jiuxin Pills prescription (15 pills loading does, maintenance 6 pills each time, three times a day.) for 180 days

Drug: Suxiao Jiuxin Pills

The placebo of Suxiao Jiuxin Pills

PLACEBO COMPARATOR

The placebo of Suxiao Jiuxin Pills prescription (15 pills loading does, maintenance 6 pills each time, three times a day.) for 180 days

Drug: The placebo of Suxiao Jiuxin Pills

Interventions

Suxiao Jiuxin PillsDRUG

Suxiao Jiuxin Pills consists Rhizoma Ligustici (Chuan xiong) and Borneolum (Bing pian).

Suxiao Jiuxin Pills
The placebo of Suxiao Jiuxin PillsDRUG

The placebo of Suxiao Jiuxin Pills is similar to Suxiao Jiuxin Pills in appearance, smell, and taste.

The placebo of Suxiao Jiuxin Pills

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meet the diagnosis of AMI, prepare for PCI reperfusion therapy;
  • Between the ages of 18-75;
  • Volunteer to participate in this study and have signed an informed consent form;
  • Have a correct understanding of the significance of drug research, and have a good compliance with the observation and evaluation.

You may not qualify if:

  • Not suitable for coronary intervention;
  • With unstable hemodynamics;
  • Platelet count\<100×109;
  • Suspected aortic dissection or acute pulmonary embolism;
  • With mechanical complications;
  • With uncontrolled acute left heart failure and pulmonary edema;
  • With known bleeding history, active bleeding, bleeding constitution, or severe hemostatic and coagulation dysfunction;
  • Meantain anticoagulants (such as warfarin or new anticoagulants);
  • Severe liver and kidney insufficiency (Child-Pugh B and above, Cr\>177μmol/L (2mg/dl) or eGFR\<45ml/min/1.73m2);
  • CTO, stent stenosis, or severe left main disease;
  • History of coronary artery bypass graft surgery;
  • Other pathophysiological conditions whose expected survival period is less than 1 year;
  • Allergic history to Suxiao Jiuxin Pills;
  • Pregnant or lactating women;
  • Participating in other clinical studies;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Central Study Contacts

Minzhou Zhang, Professor

CONTACT

+86-13924266368minzhouzhang@gzucm.edu.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2021

First Posted

March 24, 2021

Study Start

May 1, 2021

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

March 24, 2021

Record last verified: 2021-03