Effect of Rosuvastatin and Eicosapentaenoic Acid on Neoatherosclerosis: The LINK-IT Trial

NCT03192579 | Completed Phase 4 DMC

• 1 other identifier: KobeU
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aim to evaluate whether intensive lipid lowering therapy may improve the clinical outcomes in coronary artery disease patients with in-stent neoatherosclerosis, in comparison with standard therapy.

Conditions

Coronary Artery Disease Progression

Keywords

neoatherosclerosis

Outcome Measures

Primary Outcomes (1)

• Lipid index change between baseline and 12 month follow-up

  Lipid core arc was measured by every 0.2-mm interval throughout segments with NA on OCT findings. The mean lipid core arc was calculated for each lesion. Then, the lipid index was calculated by multiplying the mean lipid core arc by the lipid core longitudinal length.

  Baseline and 12 month follow-up

Secondary Outcomes (1)

• Macrophage grade change between baseline and 12 month follow-up

  Baseline and 12 month follow-up

Study Arms (2)

Standard lipid lowering therapy

EXPERIMENTAL

Start with only rosuvastatin 2.5mg and up to 20mg/day

Drug: Standard dose rosuvastatin

Intensive lipid lowering therapy

ACTIVE COMPARATOR

Start EPA and rosuvastatin 10mg/day and up to 20mg/day

Drug: EPA and high dose rosuvastatin

Interventions

EPA and high dose rosuvastatin DRUG

After randomization, patients with intensive lipid lowering therapy start EPA (1800mg/day) and high dose rosuvastatin (10mg/day) for 12 months.

Also known as: Rosuvastatin, Eicosapentaenoic acid

Intensive lipid lowering therapy

Standard dose rosuvastatin DRUG

After randomization, patients with standard lipid lowering therapy start only rosuvastatin (2.5mg/day) for 12 months.

Also known as: rosuvastatin

Standard lipid lowering therapy

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consecutive patients with stent implantation who were performed coronary angiography and OCT follow-up of the coronary arteries were candidate. During this period, OCT was performed for the following reasons: 1) planned follow-up coronary angiography and OCT for routine stent follow-up or due to other study protocols, regardless of symptoms; 2) evidence of myocardial ischemia such as silent myocardial ischemia, stable angina, or acute coronary syndrome; or 3) planned follow-up angiography for other stent segments. These patients were implanted bare metal stent, sirolimus-eluting stents (Cypher, Cordis, Miami Lakes, FL, USA), paclitaxel-eluting stents (Taxus, Boston Scientific, Natick, MA, USA), or everolimus-eluting stents (XIENCE V, Abbott Vascular, Santa Clara, CA, USA). The investigators assessed their OCT examination at the follow-up OCT time and patients who were detected NA on OCT findings were eligible for the presence study.

Sponsors & Collaborators

• Kobe University: lead

MeSH Terms

Interventions

Rosuvastatin Calcium; Eicosapentaenoic Acid

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Hiromasa Otake, ph.D

  Kobe University Graduate School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kobe University Graduate School of Medicine

Model Details: Consecutive patients with stent implantation who were performed coronary angiography and OCT follow-up of the coronary arteries were screened. The patients with neoatherosclerosis were randomly assigned to either 2.5-5mg/day of rosuvastatin therapy or 10mg/day(up to 20mg) of rosuvastatin and 1800mg/day of eicosapentaenoic acid therapy at a 1:1 ratio for 12 months.

Study Record Dates

• First Submitted: June 15, 2017
• First Posted: June 20, 2017
• Study Start: July 26, 2013
• Primary Completion: June 2, 2017
• Study Completion: June 2, 2017
• Last Updated: January 9, 2018

Record last verified: 2018-01