To Evaluate the Efficacy of Alirocumab for Neoatherosclerosis by Using OCT, in Comparison With Standard Statin Therapy (POLARIS)
Prospective Observational Study for Lesion of Neoatherosclerosis: The Efficacy of Alirocumab for the Neoatherosclerosis Reaction Investigated by Serial Optical Coherence Tomography
調査の概要
詳細な説明
The investigators investigate to evaluate the efficacy of alirocumab for in-stent neoatherosclerosis. The investigators enrolled the patient who performed drug eluting stent implantation and detected in-stent neoatherosclerosis by follow up optical coherence tomography, and categorized into two group; the patients with alirocumab and rosuvastatin the investigatorsre categorized alirocumab therapy group, and the patients with rosuvastatin alone were categorized standard statin therapy group.
The investigators compare these two group for outcomes.
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前：Hiromasa Otake, M.D., Ph.D
- 電話番号：+81-78-382-5111
- メール：hotake@med.kobe-u.ac.jp
研究連絡先のバックアップ
- 名前：Yoichiro Sugizaki, M.D.
- 電話番号：+81-78-382-5111
- メール：you0724@med.kobe-u.ac.jp
研究場所
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Hyogo
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Kobe、Hyogo、日本、650-0017
- 募集
- Kobe University Graduate School of Medicine, Department of Cardiology
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Patients with stent implantation who were performed coronary angiography and optical coherence tomography (OCT) follow-up of the coronary arteries were candidate.
These patients were implanted drug elutingstent including 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.
説明
Inclusion Criteria:
- The age at the time of consent acquisition is 20 years old or over.
- OCT Images that can be analyzed are obtained, and neoatherosclerosis existed in drug eluting stent
- lipid lowering therapy with rosuvastatin 10 mg or rosuvastatin 10 mg and aliclumab is performed.
- Baseline OCT was scheduled to be revisited within 6 to 12 months, or already performed.
- Document consent has been obtained from the subject person to this research.
Exclusion Criteria:
- Patients who have received treatment with PCSK 9 inhibitor in the past
- Patients whose treatment was interrupted before follow-up catheterization during the observation period
- Patients underwent LDL apheresis.
- In the case that the researchers judges it as inappropriate as the object of this research.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
alirocumab therapy group
patients with 10mg daily rosuvastatin and alirocumab at least 75mg every 2 weaks
|
the administration of Alirocumab at least 75mg every 2 weeks
|
|
standard statin therapy group
patient with 10mg daily rosuvastatin and never use alirocumab or other PCSK-9 inhibitor
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Lipid index change between baseline and 9 month follow-up
時間枠：Baseline and 9 month follow-up
|
Lipid core arc was measured by every 0.2-mm interval throughout segments with neoatherosclerosis (NA) on optical coherence tomography (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 9 month follow-up
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Macrophage grade change between baseline and 9 month follow-up
時間枠：Baseline and 9 month follow-up
|
Macrophage arc were measured on OCT images with NA every 0.2-mm intervals and divided 4 groups as follows: grade 0, no mac¬rophage; grade 1, localized macrophage accumulation (<30°); grade 2, clus¬tered accumulation ≥30° and <90°; grade 3, clus¬tered accumulation ≥90° and <270°; and grade 4, clustered accumulation ≥270° and <360° .
Macrophage grade was evaluated as summation of 0 to 4 grades across all cross section in NA.
|
Baseline and 9 month follow-up
|
協力者と研究者
スポンサー
捜査官
- スタディチェア：Hiromasa Otake, M.D., Ph.D、Kobe University Graduate School of Medicine
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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