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

NCT03007524 | Unknown Phase 4 DMC

• 1 other identifier: KY20160608-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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 vessel" plaque stability. Moreover, the investigators may provide mechanically evidence of clinical application of high dose rosuvastatin in patients with acute coronary syndrome.

Conditions

Acute Coronary Syndrome

Keywords

rosuvastatin; optical coherence tomography; acute coronary syndrome

Outcome Measures

Primary Outcomes (1)

• Proportion of covered struts

  6 months

Secondary Outcomes (22)

• Mean/Minimal stent diameter

  6 months

• Mean/Minimal stent area

  6 months

• Mean/Minimal stent volume

  6 months

• Mean/Minimal lumen diameter

  6 months

• Mean/Minimal lumen area

  6 months

Other Outcomes (2)

• Lipid levels

  Baseline，6 months

• Biological index

  Baseline，6 months

Study Arms (2)

High dose rosuvastatin

EXPERIMENTAL

20mg/d quaque nocte(qN), at least 6 months

Drug: High dose Rosuvastatin

Low dose rosuvastatin

ACTIVE COMPARATOR

10mg/d quaque nocte（qN）, at least 6 months

Drug: Low dose Rosuvastatin

Interventions

High dose Rosuvastatin DRUG

20mg/d qN, at least 6 months

Also known as: Rosuvastatin Calcium, Crestor

High dose rosuvastatin

Low dose Rosuvastatin DRUG

10mg/d qN, at least 6 months

Also known as: Rosuvastatin Calcium, Crestor

Low dose rosuvastatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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);
• 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;

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, 210006, China

RECRUITING

Related Publications (25)

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MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yao-Jun Zhang, PhD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

• Ze-Ning Jin, PhD

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

• Fei Ye, PhD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

• Song Lin, PhD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

• Bo Xu, MSc

  Fu Wai Hospital, Beijing, China

  STUDY DIRECTOR

Central Study Contacts

Yong-Xiang Zhu, MSc

CONTACT

zhuyongxiang_njmu@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: January 2, 2017
• Study Start: July 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2019
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

CN (1)