Peking and Rotterdam on Mission to Reduce Coronary Artery Disease (PROMISS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by Peking University Third Hospital
Sponsor:
Information provided by (Responsible Party):
Wei Gao, Peking University Third Hospital
ClinicalTrials.gov Identifier:
NCT01653119
First received: July 26, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted

July 26, 2012
July 26, 2012
April 2012
June 2015   (final data collection date for primary outcome measure)
A composite of cardiovascular mortality or a clinical diagnosis of a non-fatal ACS [ Time Frame: during 12 months follow-up ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
A composite of cardiovascular mortality or a clinical diagnosis of a non-fatal ACS [ Time Frame: during 30 days follow-up ] [ Designated as safety issue: No ]
Same as current
The proportion of any AST or ALT >3 x ULN or CK >5 x ULN [ Time Frame: during the 1-year follow up period ] [ Designated as safety issue: Yes ]
Same as current
 
Peking and Rotterdam on Mission to Reduce Coronary Artery Disease
Peking and Rotterdam on Mission to Reduce Coronary Artery Disease

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acute Coronary Syndrome
  • Diabetes Mellitus
Drug: Rosuvastatin
Both of the two groups will be given standard ACS treatment according to treatment guidelines during the following 1 year.
Other Name: Crestor
  • Active Comparator: High loading dose of rosuvastatin
    rosuvastatin 20mg/d×1w
    Intervention: Drug: Rosuvastatin
  • Active Comparator: Routine rosuvastatin therapy
    rosuvastatin 10mg/d×1w
    Intervention: Drug: Rosuvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
December 2015
June 2015   (final data collection date for primary outcome measure)

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.
Both
40 Years and older
No
Contact: Wei Gao, Master +8613901366179 dr_gaowei@medmail.com.cn
Contact: Wei Zhao +8618600017812 beate_vv@bjmu.edu.cn
China
 
NCT01653119
PUCRP-004
Yes
Wei Gao, Peking University Third Hospital
Peking University Third Hospital
Not Provided
Not Provided
Peking University Third Hospital
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP