Acute Myocardial InfarctionNCT01997294
Sequential Therapy of Atorvastatin Improve Outcomes of ST-elevated Acute Myocardial Infarction
A study testing Sequential therapy of atorvastatin in people with Acute Myocardial Infarction, run by Zhang Qi, MD at 1 site in China.
Trial summary
Statins have been approved to benefit patients underwent percutaneous coronary intervention (PCI). The current study is designed to evaluate the effectiveness and safety of Sequential Therapy of Atorvastatin in patients with ST-elevated myocardial infarction and receive PCI treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Sequential therapy of atorvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Feb 2017
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sighed informed consent
- Diagnosised as acute myocardial infarction
- Time frame less than 12 hours since the occurance of chest pain
- Aggred to receive sirolimus-eluted coronary stents
- Patients willing to accepte follow-up
Who cannot join
- Allegy to statins or with a history against statin therapy
- Allegy to any products that will be used during PPCI
- Disagreed to receive PPCI and other related therapy
- Existing sever liver dysfuntion that statins can not be used according to the guildlines
- Sever kidney dysfunction (creatinine >3mg/dl or eGFR<30ml/min)
- Sever left ventricular dysfunction (Killip grade 3)
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- Patients are currently taking medicine that may influence the use of statin
- Patients with a history of alcohol abuse or durg abuse
- Woman during pregnancy or lactation
- Patients who has attended other clinical trials
- Patients who has received PCI or CABG previously
- Patients who can not agree to accept study protocol
- Other conditions that may not sutible for the current study
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital, Dept. of Cardiology
Shanghai, Shanghai Municipality, 200025
About this study
Official title: Sequential Therapy of Atorvastatin Improving Tissue Reperfusion and Clinical Outcomes of ST-elevated Acute Myocardial Infarction Study（The STRAIT Study）
Statins have been approved to benefit patients underwent percutaneous coronary intervention (PCI). The current study is designed to evaluate the effectiveness and safety of Sequential Therapy of Atorvastatin in patients with ST-elevated myocardial infarction and receive PCI treatment.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Sequential therapy of atorvastatin
- Keywords
- sequential therapy, atorvastatin, acute myocardial infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequential therapy of atorvastatinDrug
80mg atorvastatin before PPCI and 40mg/d for 7 days after PPCI
| Study group | Role | What they receive |
|---|---|---|
| sequential therapy group | Active comparator | 80mg atorvastatin before primary PCI (PPCI) followed by 40mg/d for 7 days after PPCI followed by 20mg/d for 1 year Receives: Drug: Sequential therapy of atorvastatin |
| Usual Therapy of atorvastatin | Placebo comparator | 20mg/d before and after PPCI for 1 year Receives: Drug: Sequential therapy of atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Events (MACE) Occourance Rate
- Cardiac Death (CD)
- Non-fatal re-inarction (CK-MB, cTNI or cTNT elevation again and over 3 times higher than up normal limit accompanied with syptoms or EKG indication)
- revascularization driven by syptoms (CABG or re-PCI)
Measured: 30 days
Secondary outcomes (1)
Secondary Endpoints
- TMP and TIMI grade chage after stents implantation; EKG ST reduction
- MACE ( same definition as primary endpoints)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startJan 2013
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhang Qi, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhang Qi, MD, Shanghai Jiao Tong University School of Medicine
- Investigators
- Weifeng Shen, MD. PhD., Study director, Institute of Cardiovascular Diseases, School of Medicine, Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997294
- Sponsor's protocol ID
- RJH20130115
- Other IDs
- 2011BAI11B05
- Status last verified
- Oct 2016
- First submitted
- 22 Nov 2013
- Last updated
- 11 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Therapy of Atorvastatin Improving Tissue Reperfusion and Clinical Outcomes of ST-elevated Acute Myocardial Infarction Study（The STRAIT Study）
- ClinicalTrials.gov ID
- NCT01997294
- Acronym / sponsor ID
- RJH20130115
- Conditions
- Acute Myocardial Infarction
- Keywords
- sequential therapy, atorvastatin, acute myocardial infarction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Zhang Qi, MDUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 28 Nov 2013 (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.
Statins have been approved to benefit patients underwent percutaneous coronary intervention (PCI). The current study is designed to evaluate the effectiveness and safety of Sequential Therapy of Atorvastatin in patients with ST-elevated myocardial infarction and receive PCI treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sequential therapy group | Active comparator | Drug: Sequential therapy of atorvastatin80mg atorvastatin before primary PCI (PPCI) followed by 40mg/d for 7 days after PPCI followed by 20mg/d for 1 year |
| Usual Therapy of atorvastatin | Placebo comparator | Drug: Sequential therapy of atorvastatin20mg/d before and after PPCI for 1 year |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Sighed informed consent
- Diagnosised as acute myocardial infarction
- Time frame less than 12 hours since the occurance of chest pain
- Aggred to receive sirolimus-eluted coronary stents
- Patients willing to accepte follow-up
Key exclusion criteria (13 listed)
- Allegy to statins or with a history against statin therapy
- Allegy to any products that will be used during PPCI
- Disagreed to receive PPCI and other related therapy
- Existing sever liver dysfuntion that statins can not be used according to the guildlines
- Sever kidney dysfunction (creatinine >3mg/dl or eGFR<30ml/min)
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 |
|---|---|---|
| Sequential therapy of atorvastatin80mg atorvastatin before PPCI and 40mg/d for 7 days after PPCI | Drug | Usual Therapy of atorvastatin, sequential therapy group |
Primary outcome
Major Adverse Events (MACE) Occourance Rate
Time frame: 30 days
1. Cardiac Death (CD) 2. Non-fatal re-inarction (CK-MB, cTNI or cTNT elevation again and over 3 times higher than up normal limit accompanied with syptoms or EKG indication) 3. revascularization driven by syptoms (CABG or re-PCI)
1 secondary outcome
Secondary Endpoints
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2016.
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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.
Weifeng Shen, MD. PhD. study director
Institute of Cardiovascular Diseases, School of Medicine, Shanghai Jiao Tong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sequential therapy of atorvastatin in people with Acute Myocardial Infarction, run by Zhang Qi, MD 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 5 inclusion and 13 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 11 Oct 2016. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Events (MACE) Occourance Rate (time frame: 30 days). 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 11 Oct 2016.