China Tongxinluo Study for Myocardial Protection in Patients With Acute Myocardial Infarction
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ClinicalTrials.gov Identifier: NCT03792035 |
Recruitment Status : Unknown
Verified July 2019 by fuwaihospital, China National Center for Cardiovascular Diseases.
Recruitment status was: Recruiting
First Posted : January 3, 2019
Last Update Posted : July 31, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Myocardial Infarction | Drug: Tongxinluo Drug: Placebos | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 3796 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | China Tongxinluo Study for Myocardial Protection in Patients With Acute Myocardial Infarction |
Actual Study Start Date : | May 23, 2019 |
Estimated Primary Completion Date : | September 30, 2021 |
Estimated Study Completion Date : | December 31, 2021 |
Arm | Intervention/treatment |
---|---|
Experimental: Experimental group
First time given 8 capsules of Tongxinluo, then given 4 capsules of Tongxinluo, tid, po.Dosage form: capsule;Dose: 0.26g/capsule;Duration:1 year
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Drug: Tongxinluo
tid, po. |
Placebo Comparator: Control group
First time given 8 capsules of placebo, then given 4 capsules of placebo, tid, po.Dosage form: capsule;Dose: 0.26g/capsule;Duration:1 year
|
Drug: Placebos
tid, po. |
- MACCE [ Time Frame: 30-day ]30-day incidence of composite endpoint events comprising MACCE (including cardiovascular death, myocardial re-infarction, emergency coronary revascularization and cerebral stroke)
- Revascularization [ Time Frame: 30-day ]Incidence of revascularization of the primary endpoints
- Cerebral stroke [ Time Frame: 30-day ]Incidence of cerebral stroke of the primary endpoints
- STEMI [ Time Frame: 30-day ]30-day incidence of severe complications of STEMI including cardiogenic shock, heart failure, mechanical complications and malignant arrhythmias.
- The incidence of bleeding in BARC(Bleeding Academic Research Committee Bleeding Standard) III and V [ Time Frame: 30-day ]The incidence of bleeding in BARC(Bleeding Academic Research Committee Bleeding Standard) III and V at 30-day between 0-30%.
- MACCE [ Time Frame: 1 year ]1-year incidence of composite endpoints comprising MACCE (including cardiovascular death, myocardial re-infarction, emergency coronary revascularization and cerebral stroke), re-hospitalization due to heart failure, in-stent thrombosis and major bleeding (BARC grade III and V), and the incidence of each primary endpoint event.
- In-stent restenosis [ Time Frame: 1 year ]1-year incidence of In-stent restenosis
- All-cause mortality rate at 1 year [ Time Frame: 1 year ]Symptoms improved after treatment. Evaluate all-cause mortality rate at 1 year.
- Myocardial reperfusion and no-reflow [ Time Frame: 2 hours, 24 hours and 7 days ]Evaluation of Myocardial reperfusion and no-reflow: resolution of elevated ST-segment in ECG and incidence of no-reflow at 2h, 24h and 7 days after reperfusion therapy.
- Total white cell count [ Time Frame: 7 days, 1 month, 6 months and 1 year after medication ]Normal value: 4-10, unit: 109/L.Check at 7 days, 1 month, 6 months and 1 year to see if it is within the normal range.
- Red blood cell [ Time Frame: 7 days, 1 month, 6 months and 1 year after medication ]Normal value: 3.5-5, unit: 1012/L.Check at 7 days, 1 month, 6 months and 1 year to see if it is within the normal range.
- Hemoglobin [ Time Frame: 7 days, 1 month, 6 months and 1 year after medication ]Normal value: 110-150, unit: g/L.Check at 7 days, 1 month, 6 months and 1 year to see if it is within the normal range.
- Blood platelet count [ Time Frame: 7 days, 1 month, 6 months and 1 year after medication ]Normal value: 100-300, unit: 109/L.Check at 7 days, 1 month, 6 months and 1 year to see if it is within the normal range.
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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age>18 years;
- Within 24 hours of infarctional chest pain onset;
- ECG shows ST-segment elevation ≥0.2mV in more than 2 adjacent leads, or new left bundle branch block (LBBB);
- Voluntary participation in the study with consent forms signed.
Exclusion Criteria:
- Critically illness due to STEMI;
- Long-term (>20 min) cardio-pulmonary resuscitation (CPR);
- Suspected aortic dissection or acute pulmonary embolism;
- Explicit mechanical complications, including interventricular septum perforation, rupture of papillary muscles and chordae tendineae, or on-going or ruptured left ventricular free walls.
- Serious cardiogenic shock and do not responding to hypertensive agents;
- Uncontrolled acute left heart failure or pulmonary edema;
- Malignant arrhythmias uncontrolled by anti-arrhythmia agents;
- Bleeding history of cerebral vessels, gastrointestinal tract, respiratory tract, urinary tract or other organs within 1 month;
- Presence of active hemorrhage at any part of the body (including menstruation);
- Known hemorrhagic constitution or serious hemostasis and blood coagulation disorders;
- Current usage of anticoagulants (such as Warfarin or new anticoagulants);
- . Serious hepatorenal dysfunction [ATL≥5 ULN (upper limit of normal), Cr>134μmol/L (2mg%) or eGFR<45ml/min/1.73m2];
- Serious chronic obstructive pulmonary disease (COPD) or respiratory failure;
- . Severe infection:
- . Very weak or frailty;
- . Neuropsychiatric system diseases;
- . Malignancies;
- . Other pathophysiological conditions with expected survival time <1 year;
- Allergy to the ingredients of this investigational drug;
- Women who are in pregnancy or nursery;
- Participation in clinical study of other traditional Chinese medicine (TCM);
- Unsuitability to participate in this study due to other diseases.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03792035
Contact: Xiang-Dong Li, MD | 13263138665 | fuwai_lxd@163.com |
China, Beijing | |
Fuwai Hospital | Recruiting |
Beijing, Beijing, China, 100037 | |
Contact: Xiangdong Li, MD | |
Beijing Aerospace General Hospital | Not yet recruiting |
Beijing, Beijing, China, 100076 | |
Contact: Dong-Nan Hu, MD | |
Beijing Renhe Hospital | Recruiting |
Beijing, Beijing, China, 102600 | |
Contact: Jixiang Ge, Dean 13716826088 ge-jx2004@163.com | |
China, Hebei | |
Harrison International Peace Hospital | Not yet recruiting |
Hengshui, Hebei, China, 053000 | |
Contact: Qun Zheng, MD | |
China, Henan | |
Henan Provincial Peoples Hospital | Not yet recruiting |
Zhengzhou, Henan, China, 450003 | |
Contact: Chuan-Yu Gao, MD | |
China, Shandong | |
Taian City Central Hospital | Not yet recruiting |
Tai'an, Shandong, China, 271000 | |
Contact: Huan-Yi Zhang, MD | |
China, Tianjin | |
First Teaching Hospital of Tianjin University of TCM | Not yet recruiting |
Tianjin, Tianjin, China, 300193 | |
Contact: Jing-Yuan Mao, MD |
Principal Investigator: | Yue-Jin Yang, MD | Chinese Academy of Medical Sciences, Fuwai Hospital |
Responsible Party: | fuwaihospital, Assistant dean, China National Center for Cardiovascular Diseases |
ClinicalTrials.gov Identifier: | NCT03792035 |
Other Study ID Numbers: |
SP-YFC-03-CTS-AMI 2017YFC1700503 ( Other Grant/Funding Number: National Key R&D Program-Research ; Modernization of TCM ) |
First Posted: | January 3, 2019 Key Record Dates |
Last Update Posted: | July 31, 2019 |
Last Verified: | July 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Myocardial Infarction Infarction Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |