Peking and Rotterdam on Mission to Reduce Coronary Artery Disease

Diabetes Mellitus Clinical Trial

— PROMISS  

Official title:

Peking and Rotterdam on Mission to Reduce Coronary Artery Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01653119
• Other study ID #: PUCRP-004
• Status: Recruiting
• Phase: N/A
• First received: July 26, 2012
• Last updated: July 26, 2012
• Start date: April 2012
• Est. completion date: December 2015

Study information

• Verified date: March 2012
• Source: Peking University Third Hospital
• Contact: Wei Gao, Master
• Phone: +8613901366179
• Email: dr_gaowei[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to explore the effect of 20mg high loading dose of rosuvastatin on recurrent events in patients with established DM who is admitted for an ACS.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• • Men or women =40 years of age admitted with a clinical diagnosis of ACS. The diagnosis should be based on the combination of typical ischemic chest complaints and objective evidence of myocardial ischemia or myocardial necrosis as demonstrated by the electrocardiogram (ECG) or elevated cardiac markers, as follows:

• Typical ischemic chest pain, lasting 10 minutes or more, within the preceding 24 hours, AND either

• ECG changes indicative of myocardial ischemia within 24 hours after the onset of chest pain (ECG showing persistent or non-persistent ST-segment elevation >1.0 mm in two or more contiguous leads or dynamic ST-segment depression >1.0 mm in two or more contiguous leads) or

• Elevated biomarkers of myocardial necrosis within 24 hours after the onset of chest pain (i.e. CK-MB >1 times the upper limit of normal of the local laboratory, or Troponin-T >0.1 ng/ml.

• A diagnosis of DM type II prior to the index ACS

• Written informed consent

Exclusion Criteria:

• • Myocardial ischemia precipitated by a condition other than atherosclerotic coronary artery disease (e.g. arrhythmia, severe anemia, hypoxia, thyrotoxicosis, cocaine, severe valvular disease, hypotension).

• Severely-impaired left ventricular function (ejection fraction <30%) or end-stage congestive heart failure NYHA-class III or IV (in order to avoid lost-to-follow-up due to non-acute coronary syndrome events).

• Severe chronic kidney disease with measured or calculated glomerular filtration rate (Cockgroft-Gault or MDRD4 (Modification of Diet in Renal Disease) formula) of <30 ml/min/1.73m2, or renal dialysis.

• Co-existent condition associated with a life-expectancy <12 months, or otherwise unlikely to appear at all scheduled follow-up visits.

• Known serious or hypersensitivity reactions to HMG-CoA reductase inhibitors.

• Triglyceride (TG) level =500 mg/dL (5.65 mmol/L) at screening, because patients with very high triglyceride levels warrant treatment with agents that may increase the risk of side effects associated with statin drugs.

• Active liver disease or hepatic dysfunction, as determined by alanine aminotransferase (ALT [SGPT]) >3 x ULN or bilirubin levels >1.5 x ULN at screening.

• Myopathy.

• Not using effective contraceptive methods.

• Participation in any investigational drug study less than 30 days prior to enrolment.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Myocardial Ischemia

Intervention

Drug:
• Rosuvastatin
Both of the two groups will be given standard ACS treatment according to treatment guidelines during the following 1 year.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The proportion of any AST or ALT >3 x ULN or CK >5 x ULN		during the 1-year follow up period	Yes
Primary	A composite of cardiovascular mortality or a clinical diagnosis of a non-fatal ACS		during 12 months follow-up	No
Secondary	A composite of cardiovascular mortality or a clinical diagnosis of a non-fatal ACS		during 30 days follow-up	No