Myocardial InfarctionPhase 4NCT05000411
The Impact of Compound Danshen Dropping Pills (CDDP) on the Post-myocardial Infarction Ventricular Remodeling
A Phase 4 study testing Compound Danshen Dropping Pills (CDDP) in people with Myocardial Infarction, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Compound Danshen Dropping Pills (CDDP)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 268 participants
- Where
- 1 siteChina
- Study dates
- 25 Aug 2021to 1 Mar 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75 years, gender unlimited;
- According to the guidelines for diagnosis and treatment of acute ST segment elevation myocardial infarction (2019), patients with acute anterior ST segment elevation myocardial infarction were diagnosed;
- Patients with primary acute myocardial infarction;
- Patients who completed PCI reperfusion treatment within 12 hours after the onset of the disease;
- Patients categorized as Classes I, II or III according to Killip classification on admission;
- Subjects participated in the study voluntarily and signed informed consent.
Who cannot join
- Patients with previous cardiac insufficiency caused by other diseases (valvular heart disease, congenital heart disease, pericardial disease, arrhythmia, other non cardiac causes);
- The patients underwent coronary artery bypass graft（CABG） within 12 weeks;
- Patients undergoing cardiac resynchronization;
- Patients with left ventricular outflow tract obstruction;
- Patients with myocarditis;
- Patients with uncontrolled severe arrhythmia;
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- Patients with aortic aneurysm;
- Patients with serious liver, kidney, blood system, mental disease or systemic disease;
- Significant liver and kidney dysfunction (ALT > 2.0 times the upper limit of normal value; creatinine > 1.5 times the upper limit of normal value);
- Patients with serum potassium > 5.5mmol/l;
- Uncontrolled hypertension (higher than 180 / 110mmhg);
- Pregnant or lactating women;
- Patients allergic to compound Danshen Dropping Pills; 1
- Patients participating in clinical studies of other drugs.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Liansheng Wang, Doctor, 025 68303125, drlswang@njmu.edu.cn
About this study
Official title: The Impact of Traditional Chinese Medicine, Compound Danshen Dropping Pills (CDDP) on the Post-myocardial Infarction Ventricular Remodeling: A Multicentre, Randomized, Double-blind, Placebo-controlled, Pilot Study
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).
Read the detailed description
Background: Progressive ventricular remodeling after acute anterior wall myocardial infarction（MI）is an important factor in the occurrence and death of heart failure. Angiotensin converting enzyme inhibitors and beta-blockers can ameliorate post-MI ventricular remodeling, but high-dose therapy can't be tolerable because of hemodynamic instability in the early stage of acute mycardial infarction（AMI）. It is known that traditional Chinese medicine, compound Danshen dropping pills (CDDP) exerts protective effect on microcirculatory disturbance caused by ischemia-reperfusion injury and improves energy metabolism after acute myocardial ischemia. Experimental studies have shown CDDP may attenuate ventricular remodeling after myocardial infarction.
Methods：This study is designed to evaluate the efficacy and safety of CDDP in improving ventricular remodeling and cardiac function after acute anterior wall ST-Elevation MI(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).
Discussion：This is the first prospective study that will demonstrate the impact of CDDP on ventricular remodeling and cardiac function in patients treated with pPCI for a first acute anterior wall STEMI .This study may provide novel insights of Traditional Chinese Medicine , CDDP to improve ventricular remodeling.
- Conditions
- Myocardial Infarction
- Being tested
- Compound Danshen Dropping Pills (CDDP), Placebo
- Keywords
- Myocardial Infarction, Ventricular Remodeling, CDDP
- Medical subject headings
- Myocardial Infarction, Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compound Danshen Dropping Pills (CDDP)Drug
The patients in this group are treated with 20 tablets of Compound Danshen Dropping Pills (CDDP) before primary Percutaneous Coronary Intervention (pPCI) and 10 tablets three times a day after pPCI.
PlaceboDrug
The patients in this group take 20 tablets of placebo before primary Percutaneous Coronary Intervention (pPCI) and 10 tablets three times a day after pPCI .
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Drug: Compound Danshen Dropping Pills (CDDP) |
| Control group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ultrasonic cardiogram：left ventricle ejection fraction (LVEF)
LVEF refers to the percentage of stroke output to left ventricular end-diastolic volume and it can be examined by ultrasonic cardiogram.
Measured: Week 24
ultrasonic cardiogram：left ventricular end-diastolic volume index (LVEDVI)
LVEDVI（ml/m2）=left ventricular end-diastolic volume（ml）/body surface area（m2）. It can be examined by ultrasonic cardiogram.
Measured: Week 24
ultrasonic cardiogram：left ventricular end-systolic volume index (LVESVI)
LVESVI（ml/m2）=left ventricular end-systolic volume（ml）/body surface area（m2）. It can be examined by ultrasonic cardiogram.
Measured: Week 24
Secondary outcomes (2)
N terminal pro-B-type natriuretic peptide（NT-proBNP ）decline level
N terminal pro-B-type natriuretic peptide（NT-proBNP ）is obtained by blood test.
Measured: Day 0/ Day 3/ Day 7/ Week 4/ Week 24/ Week 48
Adverse cardiovascular events
Measured: Day 0 to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start25 Aug 2021
- Primary completion25 Aug 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 268 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000411
- Sponsor's protocol ID
- CDDP
- Status last verified
- Apr 2023
- First submitted
- 2 Aug 2021
- Last updated
- 11 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wu YJ, Deng B, Wang SB, Qiao R, Zhang XW, Lu Y, Wang L, Gu SZ, Zhang YQ, Li KQ, Yu ZL, Wu LX, Zhao SB, Zhou SL, Yang Y, Wang LS. 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. Chin J Integr Med. 2023 Dec;29(12):1059-1065. doi: 10.1007/s11655-023-3648-6. Epub 2023 Sep 1.
PubMed 37656413
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Traditional Chinese Medicine, Compound Danshen Dropping Pills (CDDP) on the Post-myocardial Infarction Ventricular Remodeling: A Multicentre, Randomized, Double-blind, Placebo-controlled, Pilot Study
- ClinicalTrials.gov ID
- NCT05000411
- Acronym / sponsor ID
- CDDP
- Conditions
- Myocardial Infarction
- Keywords
- Myocardial Infarction, Ventricular Remodeling, CDDP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 268 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- 25 Aug 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 11 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Background: Progressive ventricular remodeling after acute anterior wall myocardial infarction（MI）is an important factor in the occurrence and death of heart failure. Angiotensin converting enzyme inhibitors and beta-blockers can ameliorate post-MI ventricular remodeling, but high-dose therapy can't be tolerable because of hemodynamic instability in the early stage of acute mycardial infarction（AMI）. It is known that traditional Chinese medicine, compound Danshen dropping pills (CDDP) exerts protective effect on microcirculatory disturbance caused by ischemia-reperfusion injury and improves energy metabolism after acute myocardial ischemia. Experimental studies have shown CDDP may attenuate ventricular remodeling after myocardial infarction.
Methods：This study is designed to evaluate the efficacy and safety of CDDP in improving ventricular remodeling and cardiac function after acute anterior wall ST-Elevation MI(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).
Discussion：This is the first prospective study that will demonstrate the impact of CDDP on ventricular remodeling and cardiac function in patients treated with pPCI for a first acute anterior wall STEMI .This study may provide novel insights of Traditional Chinese Medicine , CDDP to improve ventricular remodeling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Compound Danshen Dropping Pills (CDDP) |
| Control group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18-75 years, gender unlimited;
- According to the guidelines for diagnosis and treatment of acute ST segment elevation myocardial infarction (2019), patients with acute anterior ST segment elevation myocardial infarction were diagnosed;
- Patients with primary acute myocardial infarction;
- Patients who completed PCI reperfusion treatment within 12 hours after the onset of the disease;
- Patients categorized as Classes I, II or III according to Killip classification on admission;
Key exclusion criteria (14 listed)
- Patients with previous cardiac insufficiency caused by other diseases (valvular heart disease, congenital heart disease, pericardial disease, arrhythmia, other non cardiac causes);
- The patients underwent coronary artery bypass graft（CABG） within 12 weeks;
- Patients undergoing cardiac resynchronization;
- Patients with left ventricular outflow tract obstruction;
- Patients with myocarditis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compound Danshen Dropping Pills (CDDP)The patients in this group are treated with 20 tablets of Compound Danshen Dropping Pills (CDDP) before primary Percutaneous Coronary Intervention (pPCI) and 10 tablets three times a day after pPCI. | Drug | Experimental group |
| PlaceboThe patients in this group take 20 tablets of placebo before primary Percutaneous Coronary Intervention (pPCI) and 10 tablets three times a day after pPCI . | Drug | Control group |
Primary outcome
ultrasonic cardiogram：left ventricle ejection fraction (LVEF)
Time frame: Week 24
LVEF refers to the percentage of stroke output to left ventricular end-diastolic volume and it can be examined by ultrasonic cardiogram.
ultrasonic cardiogram：left ventricular end-diastolic volume index (LVEDVI)
Time frame: Week 24
LVEDVI（ml/m2）=left ventricular end-diastolic volume（ml）/body surface area（m2）. It can be examined by ultrasonic cardiogram.
ultrasonic cardiogram：left ventricular end-systolic volume index (LVESVI)
Time frame: Week 24
LVESVI（ml/m2）=left ventricular end-systolic volume（ml）/body surface area（m2）. It can be examined by ultrasonic cardiogram.
2 secondary outcomes
N terminal pro-B-type natriuretic peptide（NT-proBNP ）decline level
Time frame: Day 0/ Day 3/ Day 7/ Week 4/ Week 24/ Week 48
Adverse cardiovascular events
Time frame: Day 0 to Week 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Derived from this study: PubMed 37656413Wu YJ, Deng B, Wang SB, Qiao R, Zhang XW, Lu Y, Wang L, Gu SZ, Zhang YQ, Li KQ, Yu ZL, Wu LX, Zhao SB, Zhou SL, Yang Y, Wang LS. 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. Chin J Integr Med. 2023 Dec;29(12):1059-1065. doi: 10.1007/s11655-023-3648-6. Epub 2023 Sep 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Compound Danshen Dropping Pills (CDDP) in people with Myocardial Infarction, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liansheng Wang (+86 13390787111, drlswang@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ultrasonic cardiogram：left ventricle ejection fraction (LVEF) (time frame: Week 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05000411, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023.