Effect and safety of salvianolate injection on patients undergoing coronary angiography or intervention

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-IPR-15005998
• Date of registration: 2015-02-16
• Prospective Registration: Yes
• Primary sponsor: Peking University Third Hospital
• Public title: Effect and safety of salvianolate injection on patients undergoing coronary angiography or intervention
• Scientific title: Effect and safety of salvianolate injection on patients undergoing coronary angiography or intervention
• Date of first enrolment: 2015-03-01
• Target sample size: salvianolate group:100;Control group:100;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=10456
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: Post-market

Countries of recruitment

China

Contacts

• Name: Gao Wei

• Name: Zhao Wei
• Affiliation: Peking University Third Hospital

Key inclusion & exclusion criteria

Inclusion criteria: 1. Age=18 years;
2. Clinical diagnosed non-ST segment elevated acute coronary syndrome or stable angina pectoris, who are planned to undergo selective coronary angiography or intervention;
3. Written informed consent
Exclusion criteria: 1. ST segment elevated acute coronary syndrome or high risk non-ST segment elevated acute coronary syndromestable angina pectoris, who are planned to undergo urgent coronary angiography or intervention;
2. Renal dialysis;
3. Intravenous or intra-artery administration of iodinated contrast media less than 7 days prior to study drug/comparator drug injection;
4. Nephrotoxic medications administration less than 24 hours prior to study drug/comparator drug injection, including diuretics, biguanides, NSAID, aminoglycosides, et al.;
5. Severely-impaired left ventricular function (ejection fraction <30%) or end-stage congestive heart failure;
6. Cardiac shock;
7. Allergy to salvianolate;
8. Have or are suspected of pregnant or nursing;
9. Previously participated in this study;
10. Participation in any investigational drug study less than 30 days prior to enrolment.

Age minimum: 18
Age maximum: 100
Gender: Both

Health Condition(s) or Problem(s) studied

coronary artery disease

Intervention(s)

salvianolate group:salvianolate injection;Control group:standard therapy;

Primary Outcome(s)

the incidence of myocardial injury post coronary artery intervention;the incidence of contrast induced nephropathy;

Secondary Outcome(s)

nterleukin-18,IL-18;neutrophil gelatinase-associated lipocalin,NGAL;kidney injury molecule-1,KIM-1;liver-type fatty acid-binding protein,L-FABP;

Source(s) of Monetary Support

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