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
  Purpose

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.


Condition Intervention
Acute Coronary Syndrome
Diabetes Mellitus
Drug: Rosuvastatin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Peking and Rotterdam on Mission to Reduce Coronary Artery Disease

Resource links provided by NLM:


Further study details as provided by Peking University Third Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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 ]

Estimated Enrollment: 1000
Study Start Date: April 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: High loading dose of rosuvastatin
rosuvastatin 20mg/d×1w
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: Routine rosuvastatin therapy
rosuvastatin 10mg/d×1w
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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01653119

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

Locations
China, Beijing
Peking University Third Hospital Recruiting
Beijing, Beijing, China, 100191
Contact: Wei Gao, Master    +8613901366179    dr_gaowei@medmail.com.cn   
Contact: Wei Zhao, Doctor    +8618600017812    beate_vv@bjmu.edu.cn   
Sponsors and Collaborators
Peking University Third Hospital
  More Information

Additional Information:
PUCRI  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Wei Gao, doctor, Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT01653119     History of Changes
Other Study ID Numbers: PUCRP-004
Study First Received: July 26, 2012
Last Updated: July 26, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Peking University Third Hospital:
Acute coronary syndrome
Diabetes mellitus
Statins
High loading dose
Recurrent events

Additional relevant MeSH terms:
Diabetes Mellitus
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Syndrome
Acute Coronary Syndrome
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Disease
Pathologic Processes
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014