Study for Xinnaining Capsule accurately intervening in the residual risk of post-acute coronary syndrome state complicated with carotid artery plaque
- Conditions
- the residual risk of Post- acute coronary syndrome state complicated with carotid artery plaque
- Registration Number
- ITMCTR1900002586
- Lead Sponsor
- Affiliated Hospital of Shandong University of TCM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Age range from 45 to 79 years, regardless of gender.
2. 15-90 days after the occurrence of acute coronary syndrome (ACS) requiring hospitalization, coronary heart disease was diagnosed by imaging.
3. CCS II~III labor angina pectoris which has been treated with combination anti-angina medication but cannot been completely controlled.
Note: Anti-angina drugs include beta blockers, long-acting nitrates, calcium antagonists.
4. Non-calcified carotid plaques can be found by carotid ultrasound detection (definition: localized thickening of the medial epithelium in either the common carotid artery or internal carotid artery wall on the left or right>=1.3mm and <=3.5mm, no significant calcification ).
5. High-sensitivity C-reactive protein (hs-CRP) 2~10mg/L.
6. Voluntary signing of informed consent.
1. History of stroke (cerebral hemorrhage, subarachnoid hemorrhage, cerebral thrombosis, cerebral embolism, and unexplained stroke) or symptomatic lower limbs arteriosclerosis occlusion disease in the past 6 months.
2. Uncontrolled grade 3 hypertension (>=180/100mmHg) or hypotension (<90/60mmHg).
3. Combined with attack stage of bronchial asthma or chronic obstructive pulmonary disease, symptomatic bradycardia (resting heart rate <55bpm) or high atrioventricular block, statin contraindications and/or statin intolerance history.
4. History of pregnancy, pregnancy preparation, abortion, breastfeeding or after childbirth in the past 6 months.
5. Severe allergies, known or likely to be allergic to the test drug or its constituents.
6. Known bleeding tendency or hemorrhagic disease.
7. Combined with severe liver and kidney dysfunction (creatinine clearance <= 60ml / min or kidney disease active period, serum transaminase >= 2 times the clinical reference limit), other serious primary disease or mental disease and malignant tumor which affecting life expectancy.
8. The investigator judges that there may be other conditions or contraindications that may affect the research.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method DCG;hs-CRP;
- Secondary Outcome Measures
Name Time Method Weekly use of nitroglycerin and its reduction rate;SAQ;Weekly angina attacks;EQ-5D;