安定した冠動脈疾患を有する患者における因子IXaの活性に対する抗剤制御による調節に関する1b相ランダム化試験
Mark Y Chan1, Mauricio G Cohen, Christopher K Dyke
1Duke Clinical Research Institute, 2400 Pratt St, Terrace Level Room 0311, Durham, NC 27705, USA.
Circulation
|May 29, 2008
まとめ
新種のRNAアプタマー療法であるREG1は,抗血小板治療を受けている冠動脈疾患の患者において,因子IXaの活性を効果的に抑制する. 薬剤対抗剤システムは,予測可能な抗凝固作用と,大きな出血事件なしに急速な逆転を示した.
科学分野:
- 心血管医学は,心臓血管医学である.
- 薬理学 薬理学とは
- トロンボシス研究研究
背景:
- 抗血小板治療を受けている安定した冠動脈疾患 (CAD) 患者のための新しい抗凝固剤の調査.
- 選択的因子IXa抑制の有効性と安全性の評価,血小板指向治療と併用.
研究 の 目的:
- REG1の安全性,耐受性,および薬物動力学を評価するために,RNAアプタマー薬剤抗剤システムが因子IXaを標的とする.
- CAD患者におけるREG1の投与量依存の抗凝固剤効果と逆転能力を決定する.
主な方法:
- アスピリンおよび/またはクロピドグレルを服用している50人のCAD患者を含むランダム化,ダブルブラインド,プラセボ対照試験.
- REG1 (RB006薬,RB007抗薬) を4つのエスカレートする用量レベルで投与する.
- 活性化された部分血小板形成時間 (aPTT) と有害事象のモニタリング.
主要な成果:
- RB006は,aPTTの量に依存する増加を示し,有効な因子IXa阻害を示した (P<0.0001).
- RB007は,1分以内に迅速にaPTTをベースラインに逆転させ,7日間リバウンド効果は見られなかった.
- 大きな出血や深刻な有害事象は報告されず,良好な耐受性を示唆しています.
結論:
- REG1は,抗血小板治療を受けているCAD患者における因子IXaの活性を成功裏に抑制し,回復した最初のRNAアプタマー薬-抗薬ペアを表しています.
- 予測可能な薬物動力学的効果と予備的な安全性プロファイルは,選択的再血管化を施した患者のさらなる調査を支持します.
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