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Efficacy and Safety of Salvianolate Injection in Elderly Patients With Unstable Angina Pectoris

NCT ID: NCT03037047

Last Updated: 2017-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-11

Study Completion Date

2018-12-31

Brief Summary

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This parallel, double blind, randomized, controlled, multi-center study will evaluate the efficacy and safety of salvianolate injection in elderly patients with unstable angina pectoris.

Detailed Description

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This parallel, double blind, randomized, controlled, multi-center study will evaluate the efficacy and safety of salvianolate injection in elderly patients with unstable angina pectoris. Patients will treated with or without salvianolate injection on the basis of conventional therapy for 14 days. The primary measures of effectiveness include the change from baseline to the end of treatment in the angina scores.(Angina score table :sum of 4 items), the variation of EKG (level of the S-T segment)., Additional measures of effectiveness include the change from baseline to the end of the treatment in the Seattle Angina Questionnaire(SAQ),EuroQol-5 Dimensions(EQ-5D) will be performed throughout the study. Patients who complete the double-blind portion of the study will be followed up 28 days. Effectiveness will be assessed at 7 days, 14 days and 28 days. Safety evaluations (incidence of adverse events,, physical examinations, laboratory tests) will be performed at at 7 days, 14 days and 28 days of the study.

Conditions

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Unstable Angina

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control group

patients will be treated by 0.9% sodium chloride injection on the basis of conventional therapy for 14 days.

Group Type PLACEBO_COMPARATOR

0.9% Sodium Chloride Injection

Intervention Type DRUG

Patients will treated with 0.9% Sodium Chloride Injection on the basis of conventional therapy for 14 days.

Experimental group

patients will be treated by salvianolate injection on the basis of conventional therapy for 14 days.

Group Type EXPERIMENTAL

salvianolate injection

Intervention Type DRUG

Patients will treated with salvianolate injection on the basis of conventional therapy for 14 days.

Interventions

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0.9% Sodium Chloride Injection

Patients will treated with 0.9% Sodium Chloride Injection on the basis of conventional therapy for 14 days.

Intervention Type DRUG

salvianolate injection

Patients will treated with salvianolate injection on the basis of conventional therapy for 14 days.

Intervention Type DRUG

Other Intervention Names

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Normal saline Salvianolate

Eligibility Criteria

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Inclusion Criteria

1. Patient in line with 1979 WHO diagnostic criteria for UA
2. Ages eligible for study: 60-85years (adult,senior)
3. Traditional Chinese medicine for CHD treatment should be stopped at least 1 week;take CHD drugs standardly
4. Participates give written informed consent

Exclusion Criteria

1. NSTE-ACS caused by non atherosclerotic disease
2. Angina pectoris caused by violent activities, fever, tachycardia, high adrenergic state, mental stress, lack of sleep, eating too full, left ventricular load increased (hypertension, aortic stenosis)
3. Angina pectoris caused byanemia, methemoglobinemia and hypoxemia
4. Abnormal thyroid function
5. Poorly controlled hypertension (systolic pressure ≥160mmHg or diastolic blood pressure ≥100mmHg)
6. Severe cardiopulmonary dysfunction
7. Severe arrhythmia (atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, sinus bradycardia (heart rate \< 55),complete left bundle branch block
8. Combined liver and kidney and hematopoietic system and other serious diseases, liver function (ALT, AST) 3 times higher than the upper limit of normal renal function, creatinine clearance rate (CrCl) less than 30 ml/min/1.73m2
9. Recent 4 weeks underwent surgery and bleeding tendency
10. Poor compliance
11. At the same time in other clinical researches
12. Allergic constitution
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Green Valley Group of China

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiaoying Li, doctor

Role: STUDY_CHAIR

Chinese PLA General Hospital

Locations

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Chinese PLA General Hospita

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hongying Liu, doctor

Role: CONTACT

Email: [email protected]

Facility Contacts

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Hongying Liu, doctor

Role: primary

References

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Cui H, Li XY, Gao XW, Lu X, Wu XP, Wang XF, Zheng XQ, Huang K, Liu F, Luo Z, Yuan HS, Sun G, Kong J, Du XH, Zheng J, Liu HY, Zhang WJ. A Prospective Randomized Multicenter Controlled Trial on Salvianolate for Treatment of Unstable Angina Pectoris in A Chinese Elderly Population. Chin J Integr Med. 2019 Oct;25(10):728-735. doi: 10.1007/s11655-019-2710-x. Epub 2019 Nov 28.

Reference Type DERIVED
PMID: 31782009 (View on PubMed)

Other Identifiers

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GV-MD-CT201601

Identifier Type: -

Identifier Source: org_study_id