The Effect of Tongguan Capsule for MicroRNA Profiles in Coronary Heart Disease Patients

NCT ID: NCT02850627

Last Updated: 2016-08-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-12-31

Brief Summary

The purpose of this study is to test the expression of microRNAs related to the syndromes after the intervention of Tongguan capsule,preliminarily to investigate the mechanism of the effects of Tongguan capsule, and provide the biological foundation of curative effect of Tongguan capsule.

Detailed Description

The primary end points is the core of the whole experiment scheme. miRNAs regulate gene expression posttranscriptionally by degrading messenger RNA (mRNA) targets and by blocking their translation Secondary endpoints will include The adverse cardiac clinical events (MACE) in terms of cardiac death,periprocedural myocardial infarction (MI),spontaneous MI and target vessel revascularization(TVR). Related parameters of qi and blood are the material basis of blood conversion and objective performance is used to evaluate the effect on Tongguan capsule on patients with blood stagnation, which can be either interpretation theory of qi deficiency and blood stagnation and mutual transformation between qi and blood can find targets through Tongguan capsule on blood . Routine laboratory tests are used for screening patients basic situation and ensure the safety of the experiment The traditional Chinese medicine syndrome scale Including the the score of deficiency of qi and score of blood stasis syndrome mainly used to identify patients with the traditional Chinese medicine syndrome type Approximately 100 patients in Coronary Heart Disease Patients with Blood Stasis Syndrome undergoing percutaneous coronary intervention will be enrolled and randomized to divided into Qi -stagnation and blood stasis, Qi- deficiency and blood stasis, after the PCI surgery, Qi deficiency and blood stasis group were randomly divided into Tongguan capsule group and the control group, and qi stagnation and blood stasis group, too ,giving patients through Tongguan capsule 3 pills three times a day(1.5g/day), once every three months follow-up, after have been followed up to six months

Conditions

Coronary Heart Disease; Acute Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Tongguan capsule

Tongguan capsule (0.5 g tid. for 6 months)

Group Type: EXPERIMENTAL

Tongguan capsule

Intervention Type: DRUG

eligible participants were randomized to receive Tongguan capsule ( 1.5 g/day for six months immediately after PCI)

placebo capsule

same volume/day of placebo capsule (0.5 g tid. for 6 months)

Group Type: PLACEBO_COMPARATOR

placebo capsule

Intervention Type: DRUG

eligible participants were randomized to receive placebo capsule ( 1.5 g/day for six months immediately after PCI)

Interventions

Tongguan capsule

eligible participants were randomized to receive Tongguan capsule ( 1.5 g/day for six months immediately after PCI)

Intervention Type: DRUG

placebo capsule

eligible participants were randomized to receive placebo capsule ( 1.5 g/day for six months immediately after PCI)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. In line with the diagnostic criteria for acute coronary syndrome (ACS), coronary angiography confirmed for coronary heart disease (CHD), parallel Percutaneous transluminal coronary angioplasty( PTCA) and/or coronary stent implantation was successful

2. Postoperative routine drug treatment

3. Traditional Chinese Medicine syndrome differentiation of qi -deficiency and qi -stagnation blood stasis or blood stasis license

4. Aged 35 to 75 years old

5. Must sign a consent form.

Exclusion Criteria

1. Renal insufficiency, the male serum creatinine > 2.5 mg/dl (> 220 umo/l), women > 2.0 mg/dl (> 175 umo/l)

2. With obvious liver disease or Alanine aminotransferase ( ALT)， Aspartate aminotransferase ( AST), 3 times higher than normal ceiling

3. Serious cardiac insufficiency (EF < 35%)

4. Uncontrolled patients with high blood pressure

5. Merger or severe valvular heart disease in acute cerebrovascular disease

6. Random blood glucose or greater tendency for 13.7 / L diabetes or glycosylated hemoglobin 9.5% or more

7. Patients with severe mental illness

8. Patients with malignant tumor or life expectancy in less than three years

9. Patients with severe hematopoietic system disease

10. Refused to sign a consent form, or estimated compliance is poorer, follow-up possibilities claim;

11. Pregnancy or ready to pregnant women, nursing mothers;

12. Participated in nearly three months, or is in other clinical subjects . -

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Provincial Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Huizheng Zhu

physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Minzhou Zhang, MD

Role: STUDY_DIRECTOR

Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine

Huizheng Zhu, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine

Locations

Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Huizheng Zhu, PHD

Role: CONTACT

754357604@qq.com

86-20-81887233 ext. 32808

Facility Contacts

Minzhou Zhang, MD

Role: primary

1542377671@qq.com

86-20-81887233 ext. 32808

Other Identifiers

B2015-129-01

Identifier Type: -

Identifier Source: org_study_id