NCT03037047

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2016

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 31, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2017

Enrollment Period

1.6 years

First QC Date

January 20, 2017

Last Update Submit

January 27, 2017

Conditions

Unstable Angina

Outcome Measures

Primary Outcomes (1)

  • symptom of angina pectoris

    up to 14 days

Secondary Outcomes (4)

  • Seattle angina scale score

    up to 28 days

  • EQ-5D health scale

    up to 28 days

  • thrombolysis in myocardial infarction risk score

    up to 28 days

  • Incidence of cardiovascular and cerebrovascular events

    up to 28 days

Study Arms (2)

Control group

PLACEBO COMPARATOR

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

Drug: 0.9% Sodium Chloride Injection

Experimental group

EXPERIMENTAL

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

Drug: salvianolate injection

Interventions

0.9% Sodium Chloride InjectionDRUG

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

Also known as: Normal saline
Control group
salvianolate injectionDRUG

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

Also known as: Salvianolate
Experimental group

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • NSTE-ACS caused by non atherosclerotic disease
  • 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)
  • Angina pectoris caused byanemia, methemoglobinemia and hypoxemia
  • Abnormal thyroid function
  • Poorly controlled hypertension (systolic pressure ≥160mmHg or diastolic blood pressure ≥100mmHg)
  • Severe cardiopulmonary dysfunction
  • Severe arrhythmia (atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, sinus bradycardia (heart rate \< 55),complete left bundle branch block
  • 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
  • Recent 4 weeks underwent surgery and bleeding tendency
  • Poor compliance
  • At the same time in other clinical researches
  • Allergic constitution

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospita

Beijing, Beijing Municipality, 100853, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31782009DERIVED

MeSH Terms

Conditions

Angina, Unstable

Interventions

Sodium ChlorideSaline Solutionsalvianolate

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Xiaoying Li, doctor

    Chinese PLA General Hospital

    STUDY CHAIR

Central Study Contacts

Hongying Liu, doctor

CONTACT

xiaowanzi010@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2017

First Posted

January 31, 2017

Study Start

May 11, 2016

Primary Completion

December 31, 2017

Study Completion

December 31, 2018

Last Updated

January 31, 2017

Record last verified: 2017-01

Locations

CN(1)