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NCT05000411

The Impact of Compound Danshen Dropping Pills (CDDP) on the Post-myocardial Infarction Ventricular Remodeling

Status unknown Phase 4 Last updated 11 April 2023
What this trial tests

Phase 4 trial testing Compound Danshen Dropping Pills (CDDP) in Myocardial Infarction in 268 participants. Status unknown.

Timeline
25 August 2021
Primary endpoint
25 August 2023
1 March 2024

Quick facts

Lead sponsorThe First Affiliated Hospital with Nanjing Medical University
PhasePhase 4
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment268
Start date25 August 2021
Primary completion25 August 2023
Estimated completion1 March 2024
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Who can join

Adults 18 to 75, any sex, with Myocardial Infarction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is designed to evaluate the efficacy and safety of compound Danshen dropping pills (CDDP) in improving ventricular remodeling and cardiac function after acute anterior wall ST-Elevation myocardial infarction(STEMI). 268 patients with acute anterior wall STEMI after primary Percutaneous Coronary Intervention (pPCI) are randomly assigned 1:1 to CDDP group(n=134) and control group(n=134) with follow-up of 24 weeks. Both groups are treated with standard therapy of STEMI, with the CDDP group administrating 20 tablets of CDDP before pPCI and 10 tablets three times a day after pPCI and the control group treated with placebo at the same time. The primary endpoint is 24-week echocardiographic including left ventricle ejection fraction (LVEF) , left ventricular end-diastolic volume index (LVEDVI) and left ventricular end-systolic volume index (LVESVI).The secondary endpoint is the change in N terminal pro-B-type natriuretic peptide(NT-proBNP )level, arrhythmia and cardiovascular events (death, cardiac arrest or cardiopulmonary resuscitation, hospitalization due to heart failure or angina pectoris).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Effects of Compound Danshen Dripping Pills on Ventricular Remodeling and Cardiac Function after Acute Anterior Wall ST-Segment Elevation Myocardial Infarction (CODE-AAMI): Protocol for a Randomized Placebo-Controlled Trial.
    Wu YJ, Deng B, Wang SB, Qiao R, et al · · 2023 · cited 4× · PMID 37656413 · DOI 10.1007/s11655-023-3648-6
  2. Novel perspectives on the therapeutic role of cryptotanshinone in the management of stem cell behaviors for high-incidence diseases.
    Guo X, Ma R, Wang M, Wui-Man Lau B, et al · · 2022 · cited 2× · PMID 36046823 · DOI 10.3389/fphar.2022.971444

Verify or expand the search:

Other recruiting trials for Myocardial Infarction

Currently open trials in the same condition.

Other The First Affiliated Hospital with Nanjing Medical University trials

Trials by the same sponsor.

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Data sources for this page

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