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Acute Coronary SyndromePhase 4CROWN-1NCT03007524

Early Vascular Healing in Acute Coronary Syndrome Patients With Different Doses of Rosuvastatin

A Phase 4 study testing High dose Rosuvastatin and Low dose Rosuvastatin in people with Acute Coronary Syndrome, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a prospective, randomized trial comparing different doses of rosuvastatin in patients with acute coronary syndrome post drug-eluting stents implantation. Through the study, the investigators aim to evaluate the effects of high dose rosuvastatin calcium on "target vessel" endothelialization and "non-target… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Acute Coronary Syndrome
What is being tested?
High dose Rosuvastatin and Low dose Rosuvastatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteChina
Study dates
Jul 2016to Dec 2019
Phase
Phase 4
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 to 75 years male or non-pregnant female;
  • Clinical evidence of unstable angina or non ST segment elevation myocardial infarction (NSTEMI);
  • The patient has up to two de novo native coronary lesions in different epicardial vessels;
  • Target lesion diameter stenosis ≧70%(visually estimated);
  • Each target lesion must be treated with maximal 2 stents (except the bailout stenting);
  • Low density lipoprotein (LDL) higher than 100mg/dL or lower than 100mg/dL but have taken statin drugs less than 1 month before enrolled;
  • Patient is an acceptable candidate for emergency coronary artery bypass grafting;
  • The patient is able to understand the aim of this study, provide voluntarily written informed content and agree to the follow-up visits including angiographic、multislice spiral computed tomography(MSCT) and optical coherence tomography(OCT) examinations;

Who cannot join

  • Any acute myocardial infarction within the past 1 months; myocardial enzyme not back to normal after myocardial infarction;
  • Chronic total occlusive lesion, severe left main coronary artery disease, orifice lesion, 3-vessel disease, bifurcation lesions (with side branch diameter greater than 2 mm, orifice diameter stenosis greater than or equal to 50%, or side branch need to be protected by guidewire or balloon), OCT imaging is not suitable for the lesion site or OCT imaging is incomplete, Target lesion located in previous venous or arterial bypass grafts, Target lesion has visible thrombus, intercurrent infection, or other inflammatory diseases.;
  • Heavily calcified lesions, severely tortuous lesions, lesions cannot be well pre-dilated and/or unsuitable of the stent crossover/expansion;
  • In-stent restenosis lesions;
  • Prior percutaneous coronary intervention(PCI) within the past 1 year; plan to possibly have re-intervention within 1 year post index-procedure; previous PCI more than 1 year at the target vessel;
  • Instability of hemodynamic or respiratory cycle, such as cardiogenic shock, Heart failure with severe symptoms (over New York Heart Association III(NYHA III)) or left ventricular ejection fraction less than 40% (UCG or left ventricle radiography);
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  • Known renal insufficiency (e.g, Glomerular filtration rate(eGFR) <60 ml/kg/m2 or serum creatinine level of >2.5 mg/dL, or subject on dialysis);
  • History of bleeding tendency, active peptic ulcer and cerebral hemorrhage or retinal hemorrhage, and a half years history of stroke, antiplatelet agents and anticoagulants therapy contraindications to anticoagulation in patients;
  • Patients have been used statins and other lipid-lowering drug treatment more than 1 month before enrolled,patients allergy to rosuvastatin or use rosuvastatin with contraindications,patients allergy to aspirin, clopidogrel or ticagrelor, heparin, contrast agent, polymer, zotarolimus and metal;
  • Life expectancy <6 months;
  • Currently participating in an investigational drug or another device study that has not completed the primary endpoint;
  • Unable or unwilling to comply with the protocol or not expected to complete the study period, including its follow-up requirements;
  • The patient is a recipient of a heart transplant;
  • Unstable arrhythmia, such as high risk ventricular contraction, ventricular arrhythmia;
  • With the need of chemotherapy in 30 days due to malignancy;
  • Patients with immune suppression or autoimmune diseases planning to have or currently receive immunosuppressive therapy;
  • Patients planning to have or currently receive long-term anticoagulation therapy;
  • Patients may receive surgery within 6 months post index-procedure in which needs to stop aspirin, clopidogrel or ticagrelor;
  • Neutropenia (<1000 neutrophils/mm3), Thrombocytopenia (<100,000 platelets/mm3), Confirmed or suspected diagnosis of liver diseases;
  • Patients with diffuse peripheral vascular disease which precludes 6 French unit(6F) sheath insertion;

Trial locations and contacts

1 site in 1 country.

Yong-Xiang Zhu, MSc contact

zhuyongxiang_njmu@163.com

China1 site, 1 recruiting

  • Nanjing First Hospital, Nanjing Medical University

    Nanjing, Jiangsu, 210006

    Zhang Yao-Jun, MD

    Zhu Yong-Xiang, MSC

    Recruiting

Other trials in China

About this study

Official title: A Randomized Comparison of Low-dose Versus High-dose Rosuvastatin on Optical Coherence Tomography Based Early Vascular Healing for Patients With Acute Coronary Syndrome

This is a prospective, randomized trial comparing different doses of rosuvastatin in patients with acute coronary syndrome post drug-eluting stents implantation. Through the study, the investigators aim to evaluate the effects of high dose rosuvastatin calcium on "target vessel" endothelialization and "non-target vessel" plaque stability. Moreover, the investigators may provide mechanically evidence of clinical application of high dose rosuvastatin in patients with acute coronary syndrome.

Read the detailed description

This is a prospective, multicenter, randomized controlled clinical trial comparing different doses of rosuvastatin in patients with acute coronary syndrome post drug-eluting stents implantation. In total, the investigators plan to recruit 80 patients with acute coronary syndrome (but no acute ST-segment elevation myocardial infarction) participating in the study. After signing informed consent form, the patients will be randomly assigned into high dose rosuvastatin and low dose rosuvastatin groups (40 cases in each group) by a computer generated random sequence table on a ratio of 1:1. Patients in the high-dose group will be prescribed rosuvastatin calcium of 20mg/d at least 6 months post index procedure, while patients in low dose group will have rosuvastatin calcium of 10mg/d, also at least 6 months. Additionally, all patients will receive dual antiplatelet therapy (oral aspirin 100mg qd, clopidogrel 75mg qd or ticagrelor 90 mg bid). Clinical follow up (telephone or out-patient follow-up) will be scheduled at 30 days, 6 months, 1 year, 2 years and 3 years. Optical coherence tomography examinations will be performed at 6 months. Neointimal hyperplasia, stent strut coverage and thin cap fibroatheroma are primary observational parameters. Multi-slices CT are optional pre-/post-procedure and at 3 years follow-up. All clinical data will be collected and managed by statistical center, clinical endpoint adjudication committee. All imaging modalities data will be collected and analysed by an independent imaging core laboratory.

Being tested
High dose Rosuvastatin, Low dose Rosuvastatin
Keywords
rosuvastatin, optical coherence tomography, acute coronary syndrome
Medical subject headings
Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High dose RosuvastatinDrug

    Also called Rosuvastatin Calcium, Crestor

    20mg/d qN, at least 6 months

  • Low dose RosuvastatinDrug

    Also called Rosuvastatin Calcium, Crestor

    10mg/d qN, at least 6 months

Study groups in NCT03007524
Study groupRoleWhat they receive
High dose rosuvastatinExperimental20mg/d quaque nocte(qN), at least 6 months
Receives: Drug: High dose Rosuvastatin
Low dose rosuvastatinActive comparator10mg/d quaque nocte（qN）, at least 6 months
Receives: Drug: Low dose Rosuvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of covered struts

    Measured: 6 months

Secondary outcomes (22)

  1. Mean/Minimal stent diameter

    Measured: 6 months

  2. Mean/Minimal stent area

    Measured: 6 months

  3. Mean/Minimal stent volume

    Measured: 6 months

  4. Mean/Minimal lumen diameter

    Measured: 6 months

  5. Mean/Minimal lumen area

    Measured: 6 months

  6. Mean/Minimal lumen volume

    Measured: 6 months

  7. Mean/Minimal vessel diameter

    Measured: 6 months

  8. Mean/Minimal vessel area

    Measured: 6 months

  9. Mean/Minimal vessel volume

    Measured: 6 months

  10. Mean/Minimal thickness of stent strut coverage

    Measured: 6 months

  11. thin cap fibroatheroma(TCFA)

    Measured: 6 months

  12. Cap thickness of thin cap fibroatheroma(TCFA)

    Measured: 6 months

  13. Neointimal Hyperplasia area

    Measured: 6 months

  14. Neointimal Hyperplasia volume

    Measured: 6 months

  15. Incomplete strut apposition

    Measured: 6 months

  16. Device-oriented composite endpoint

    Measured: 1 and 6 months, 1, 2, 3 years

  17. Cardiac death

    Measured: 1 and 6 months, 1, 2, 3 years

  18. Non-fatal myocardial infarction

    Measured: 1 and 6 months, 1, 2, 3 years

  19. All revascularization

    Measured: 1 and 6 months, 1, 2, 3 years

  20. target lesion revascularization

    Measured: 1 and 6 months, 1, 2, 3 years

  21. target vessel revascularization

    Measured: 1 and 6 months, 1, 2, 3 years

  22. stent thrombosis

    Measured: 1 and 6 months, 1, 2, 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2017 (estimated)
  2. Study startJul 2016
  3. Primary completionDec 2017 (estimated)
  4. Study completionDec 2019 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03007524
Sponsor's protocol ID
KY20160608-02
Acronym
CROWN-1
Status last verified
Feb 2017
First submitted
12 Jul 2016
Last updated
23 Feb 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Morice MC, Serruys PW, Barragan P, Bode C, Van Es GA, Stoll HP, Snead D, Mauri L, Cutlip DE, Sousa E. Long-term clinical outcomes with sirolimus-eluting coronary stents: five-year results of the RAVEL trial. J Am Coll Cardiol. 2007 Oct 2;50(14):1299-304. doi: 10.1016/j.jacc.2007.06.029. Epub 2007 Sep 17.

    PubMed 17903626

  • Grech ED. ABC of interventional cardiology: percutaneous coronary intervention. I: history and development. BMJ. 2003 May 17;326(7398):1080-2. doi: 10.1136/bmj.326.7398.1080. No abstract available.

    PubMed 12750213

  • Gottsauner-Wolf M, Zasmeta G, Hornykewycz S, Nikfardjam M, Stepan E, Wexberg P, Zorn G, Glogar D, Probst P, Maurer G, Huber K. Plasma levels of C-reactive protein after coronary stent implantation. Eur Heart J. 2000 Jul;21(14):1152-8. doi: 10.1053/euhj.1999.1987.

    PubMed 10924298

  • Walter DH, Fichtlscherer S, Britten MB, Rosin P, Auch-Schwelk W, Schachinger V, Zeiher AM. Statin therapy, inflammation and recurrent coronary events in patients following coronary stent implantation. J Am Coll Cardiol. 2001 Dec;38(7):2006-12. doi: 10.1016/s0735-1097(01)01662-x.

    PubMed 11738308

  • Losordo DW, Isner JM, Diaz-Sandoval LJ. Endothelial recovery: the next target in restenosis prevention. Circulation. 2003 Jun 3;107(21):2635-7. doi: 10.1161/01.CIR.0000071083.31270.C3. No abstract available.

    PubMed 12782613

  • Komatsu R, Ueda M, Naruko T, Kojima A, Becker AE. Neointimal tissue response at sites of coronary stenting in humans: macroscopic, histological, and immunohistochemical analyses. Circulation. 1998 Jul 21;98(3):224-33. doi: 10.1161/01.cir.98.3.224.

    PubMed 9697822

  • Mora S, Glynn RJ, Hsia J, MacFadyen JG, Genest J, Ridker PM. Statins for the primary prevention of cardiovascular events in women with elevated high-sensitivity C-reactive protein or dyslipidemia: results from the Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) and meta-analysis of women from primary prevention trials. Circulation. 2010 Mar 9;121(9):1069-77. doi: 10.1161/CIRCULATIONAHA.109.906479. Epub 2010 Feb 22.

    PubMed 20176986

  • Cholesterol Treatment Trialists' (CTT) Collaborators; Kearney PM, Blackwell L, Collins R, Keech A, Simes J, Peto R, Armitage J, Baigent C. Efficacy of cholesterol-lowering therapy in 18,686 people with diabetes in 14 randomised trials of statins: a meta-analysis. Lancet. 2008 Jan 12;371(9607):117-25. doi: 10.1016/S0140-6736(08)60104-X.

    PubMed 18191683

  • Cholesterol Treatment Trialists' (CTT) Collaboration; Baigent C, Blackwell L, Emberson J, Holland LE, Reith C, Bhala N, Peto R, Barnes EH, Keech A, Simes J, Collins R. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010 Nov 13;376(9753):1670-81. doi: 10.1016/S0140-6736(10)61350-5. Epub 2010 Nov 8.

    PubMed 21067804

  • Cholesterol Treatment Trialists' (CTT) Collaborators; Mihaylova B, Emberson J, Blackwell L, Keech A, Simes J, Barnes EH, Voysey M, Gray A, Collins R, Baigent C. The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials. Lancet. 2012 Aug 11;380(9841):581-90. doi: 10.1016/S0140-6736(12)60367-5. Epub 2012 May 17.

    PubMed 22607822

  • Brugts JJ, Yetgin T, Hoeks SE, Gotto AM, Shepherd J, Westendorp RG, de Craen AJ, Knopp RH, Nakamura H, Ridker P, van Domburg R, Deckers JW. The benefits of statins in people without established cardiovascular disease but with cardiovascular risk factors: meta-analysis of randomised controlled trials. BMJ. 2009 Jun 30;338:b2376. doi: 10.1136/bmj.b2376.

    PubMed 19567909

  • Hou W, Lv J, Perkovic V, Yang L, Zhao N, Jardine MJ, Cass A, Zhang H, Wang H. Effect of statin therapy on cardiovascular and renal outcomes in patients with chronic kidney disease: a systematic review and meta-analysis. Eur Heart J. 2013 Jun;34(24):1807-17. doi: 10.1093/eurheartj/eht065. Epub 2013 Mar 6.

    PubMed 23470492

  • Ray KK, Cannon CP, Ganz P. Beyond lipid lowering: What have we learned about the benefits of statins from the acute coronary syndromes trials? Am J Cardiol. 2006 Dec 4;98(11A):18P-25P. doi: 10.1016/j.amjcard.2006.09.016. Epub 2006 Sep 29.

    PubMed 17126675

  • Almuti K, Rimawi R, Spevack D, Ostfeld RJ. Effects of statins beyond lipid lowering: potential for clinical benefits. Int J Cardiol. 2006 Apr 28;109(1):7-15. doi: 10.1016/j.ijcard.2005.05.056. Epub 2005 Jul 28.

    PubMed 16054715

  • Liu T, Li L, Korantzopoulos P, Liu E, Li G. Statin use and development of atrial fibrillation: a systematic review and meta-analysis of randomized clinical trials and observational studies. Int J Cardiol. 2008 May 23;126(2):160-70. doi: 10.1016/j.ijcard.2007.07.137. Epub 2007 Nov 26.

    PubMed 18031847

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing High dose Rosuvastatin and Low dose Rosuvastatin in people with Acute Coronary Syndrome, run by Nanjing First Hospital, Nanjing Medical University 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 8 inclusion and 20 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 23 Feb 2017. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Yong-Xiang Zhu, MSc (zhuyongxiang_njmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of covered struts (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03007524, which also lists 25 linked publications.

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 23 Feb 2017.

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