Acute Coronary SyndromePROMISSNCT01653119
Peking and Rotterdam on Mission to Reduce Coronary Artery Disease
A study testing Rosuvastatin in people with Acute Coronary Syndrome and Diabetes Mellitus, run by Peking University Third Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Diabetes Mellitus
- What is being tested?
- Rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Apr 2012to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- • 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Wei Gao, Master, +8613901366179, dr_gaowei@medmail.com.cn
Wei Zhao, Doctor, +8618600017812, beate_vv@bjmu.edu.cn
About this study
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.
- Conditions
- Acute Coronary Syndrome, Diabetes Mellitus
- Being tested
- Rosuvastatin
- Keywords
- Acute coronary syndrome, Diabetes mellitus, Statins, High loading dose, Recurrent events
- Medical subject headings
- Acute Coronary Syndrome, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Crestor
Both of the two groups will be given standard ACS treatment according to treatment guidelines during the following 1 year.
| Study group | Role | What they receive |
|---|---|---|
| High loading dose of rosuvastatin | Active comparator | rosuvastatin 20mg/d×1w Receives: Drug: Rosuvastatin |
| Routine rosuvastatin therapy | Active comparator | rosuvastatin 10mg/d×1w Receives: Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite of cardiovascular mortality or a clinical diagnosis of a non-fatal ACS
Measured: during 12 months follow-up
Secondary outcomes (1)
A composite of cardiovascular mortality or a clinical diagnosis of a non-fatal ACS
Measured: during 30 days follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2012 (estimated)
- Study startApr 2012
- Primary completionJun 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Gao, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01653119
- Sponsor's protocol ID
- PUCRP-004
- Acronym
- PROMISS
- Status last verified
- Mar 2012
- First submitted
- 26 Jul 2012
- Last updated
- 30 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peking and Rotterdam on Mission to Reduce Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01653119
- Acronym / sponsor ID
- PROMISS / PUCRP-004
- Conditions
- Acute Coronary Syndrome, Diabetes Mellitus
- Keywords
- Acute coronary syndrome, Diabetes mellitus, Statins, High loading dose, Recurrent events
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 30 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High loading dose of rosuvastatin | Active comparator | Drug: Rosuvastatinrosuvastatin 20mg/d×1w |
| Routine rosuvastatin therapy | Active comparator | Drug: Rosuvastatinrosuvastatin 10mg/d×1w |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- • 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.
Key exclusion criteria (10 listed)
- • Myocardial ischemia precipitated by a condition other than atherosclerotic coronary artery disease (e.g. arrhythmia, severe anemia, hypoxia, thyrotoxicosis, cocaine, severe valvular disease, hypotension).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RosuvastatinAlso: CrestorBoth of the two groups will be given standard ACS treatment according to treatment guidelines during the following 1 year. | Drug | High loading dose of rosuvastatin, Routine rosuvastatin therapy |
Primary outcome
A composite of cardiovascular mortality or a clinical diagnosis of a non-fatal ACS
Time frame: during 12 months follow-up
1 secondary outcome
A composite of cardiovascular mortality or a clinical diagnosis of a non-fatal ACS
Time frame: during 30 days follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rosuvastatin in people with Acute Coronary Syndrome and Diabetes Mellitus, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Gao, Master (+8613901366179, dr_gaowei@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite of cardiovascular mortality or a clinical diagnosis of a non-fatal ACS (time frame: during 12 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2012.