CClinicalTrials.gg
Status unknownNCT01653119PROMISSUpdated Jul 30, 2012

Peking and Rotterdam on Mission to Reduce Coronary Artery Disease

An interventional study of Rosuvastatin in Acute Coronary Syndrome and Diabetes Mellitus, sponsored by Peking University Third Hospital. Status unknown at 1 site in China. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2012-07-30.

Sponsored by Peking University Third Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Coronary Syndrome
  • Diabetes Mellitus

Keywords

  • Acute coronary syndrome
  • Diabetes mellitus
  • Statins
  • High loading dose
  • Recurrent events
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 123 across 3,435 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,000 participants (estimated)

Study arms

  • Active comparator
    High loading dose of rosuvastatin

    rosuvastatin 20mg/d×1w

    Drug: Rosuvastatin

  • Active comparator
    Routine rosuvastatin therapy

    rosuvastatin 10mg/d×1w

    Drug: Rosuvastatin

Interventions

  • DrugRosuvastatin

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

    Also known as: Crestor

06

What researchers measure

Primary outcomes

  1. A composite of cardiovascular mortality or a clinical diagnosis of a non-fatal ACS

    Time frame: during 12 months follow-up

Secondary outcomes

  1. A composite of cardiovascular mortality or a clinical diagnosis of a non-fatal ACS

    Time frame: during 30 days follow-up

Other outcomes

  1. The proportion of any AST or ALT >3 x ULN or CK >5 x ULN

    Time frame: during the 1-year follow up period

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01653119
Lead sponsor
Peking University Third Hospital
Responsible party
Wei Gao (doctor, Peking University Third Hospital) — Principal investigator
First posted
Jul 30, 2012
Start date
Apr 2012
Primary completion
Jun 2015 (estimated)
Completion
Dec 2015 (estimated)
Last update
Jul 30, 2012

Study contacts

Wei Gao, Master
Contact
dr_gaowei@medmail.com.cn
+8613901366179
Wei Zhao
Contact
beate_vv@bjmu.edu.cn
+8618600017812

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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