drugset / Trial / NCT06308952
Atorvastatin Pretreatment in Cerebrovascular Events (APICES) After Flow Diverter Implantation
Phase 4
Recruiting
354 enrolled
Duan Chuanzhi
Beijing Tiantan Hospital · collabDongguan Kanghua Hospital · collabDongguan People's Hospital · collabEighth Affiliated Hospital, Sun Yat-sen University · collabFirst Affiliated Hospital of Chongqing Medical University · collabFirst Affiliated Hospital of Harbin Medical University · collabFirst Affiliated Hospital of Jinan University · collabFirst Hospital of Shijiazhuang City · collabGuangdong 999 Brain Hospital · collabPeking Union Medical College Hospital · collabShanxi Cardiovascular Hospital · collabShenzhen Second People's Hospital · collabThe First Affiliated Hospital of Zhengzhou University · collabTianjin Huanhu Hospital · collabXinqiao Hospital of Chongqing · collabZhuHai Hospital · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
APICES trial is an investigator-initiated, multicenter, multicenter, randomized, double-blind, placebo-controlled clinical trial that plans to enroll 396 patients with a 1-year follow-up, including a neurovascular imaging examination \[digital subtraction angiography (DSA), CT angiography (CTA) or magnetic resonance angiography (MRA)\] at 6 months after index treatment. It was designed in compliance with the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice guidelines. The study was approved by the Ethics Committee of Zhujiang Hospital of South Medical University (2024-KY-032-02) and registered at ClinicalTrials.gov (NCT06308952). The participants will be recruited from twelve advanced stroke centers in China.
Timeline
- Start
- 2024-07-30
- Primary completion
- 2027-12-01
- Completion
- 2027-12-31
Publications
- Background Luo B, Kang H, Zhang H, Li T, Liu J, Song D, Zhao Y, Guan S, Maimaitili A, Wang Y, Feng W, Wang Y, Wan J, Mao G, Shi H, Yang X. Pipeline Embolization device for intracranial aneurysms in a large Chinese cohort: factors related to aneurysm occlusion. Ther Adv Neurol Disord. 2020 Nov 2;13:1756286420967828. doi: 10.1177/1756286420967828. eCollection 2020.
- Results Vergouwen MD, Jong-Tjien-Fa AV, Algra A, Rinkel GJ. Time trends in causes of death after aneurysmal subarachnoid hemorrhage: A hospital-based study. Neurology. 2016 Jan 5;86(1):59-63. doi: 10.1212/WNL.0000000000002239. Epub 2015 Nov 20.
- Results Huang C, Ma G, Tong X, Feng X, Wen Z, Huang M, Xu A, Yuan H, Shi H, Lin J, Li C, Ge R, Huang J, Peng C, Zhu Y, Wang T, Huang C, Guo Z, Liang S, Su S, Zhang X, Li X, Liu A, Duan CZ. Comparison of Pipeline embolization device versus Tubridge embolization device in unruptured intracranial aneurysms: a multicenter, propensity score matched study. J Neurointerv Surg. 2024 May 6;17(5):467-474. doi: 10.1136/jnis-2024-021623.
- Results Hanel RA, Cortez GM, Lopes DK, Nelson PK, Siddiqui AH, Jabbour P, Mendes Pereira V, Istvan IS, Zaidat OO, Bettegowda C, Colby GP, Mokin M, Schirmer CM, Hellinger FR, Given C, Krings T, Taussky P, Toth G, Fraser JF, Chen M, Priest R, Kan P, Fiorella D, Frei D, Aagaard-Kienitz B, Diaz O, Malek AM, Cawley CM, Puri AS, Kallmes DF. Prospective study on embolization of intracranial aneurysms with the pipeline device (PREMIER study): 3-year results with the application of a flow diverter specific occlusion classification. J Neurointerv Surg. 2023 Mar;15(3):248-254. doi: 10.1136/neurintsurg-2021-018501. Epub 2022 Mar 15.
- Results Qi P, Tong X, Liang X, Xue X, Wu Z, Feng X, Zhang M, Jiang Z, Wang D, Liu A. Flow diversion for posterior circulation aneurysms: a multicenter retrospective study. Ther Adv Neurol Disord. 2023 Jun 8;16:17562864231176187. doi: 10.1177/17562864231176187. eCollection 2023.
- Results Hanel RA, Cortez GM, Coon AL, Kan P, Taussky P, Wakhloo AK, Welch BG, Dogan A, Bain M, De Vries J, Ebersole K, Meyers PM; SCENT Investigator Group. Surpass Intracranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide-Neck Aneurysms - SCENT: 3-year outcomes. J Neurointerv Surg. 2023 Nov;15(11):1084-1089. doi: 10.1136/jnis-2022-019512. Epub 2022 Nov 14.
- Results Kang H, Zhou Y, Luo B, Lv N, Zhang H, Li T, Song D, Zhao Y, Guan S, Maimaitili A, Wang Y, Feng W, Wang Y, Wan J, Mao G, Shi H, Yang X, Liu J. Pipeline Embolization Device for Intracranial Aneurysms in a Large Chinese Cohort: Complication Risk Factor Analysis. Neurotherapeutics. 2021 Apr;18(2):1198-1206. doi: 10.1007/s13311-020-00990-8. Epub 2021 Jan 14.
- Results Kallmes DF, Hanel R, Lopes D, Boccardi E, Bonafe A, Cekirge S, Fiorella D, Jabbour P, Levy E, McDougall C, Siddiqui A, Szikora I, Woo H, Albuquerque F, Bozorgchami H, Dashti SR, Delgado Almandoz JE, Kelly ME, Turner R 4th, Woodward BK, Brinjikji W, Lanzino G, Lylyk P. International retrospective study of the pipeline embolization device: a multicenter aneurysm treatment study. AJNR Am J Neuroradiol. 2015 Jan;36(1):108-15. doi: 10.3174/ajnr.A4111. Epub 2014 Oct 29.
- Results Colby GP, Bender MT, Lin LM, Beaty N, Caplan JM, Jiang B, Westbroek EM, Varjavand B, Campos JK, Huang J, Tamargo RJ, Coon AL. Declining complication rates with flow diversion of anterior circulation aneurysms after introduction of the Pipeline Flex: analysis of a single-institution series of 568 cases. J Neurosurg. 2018 Dec 1;129(6):1475-1481. doi: 10.3171/2017.7.JNS171289. Epub 2018 Jan 12.
- Results Zhang H, Zhang H, Liu J, Song D, Zhao Y, Guan S, Maimaitili A, Wang Y, Feng W, Wang Y, Wan J, Mao G, Shi H, Luo B, Shao Q, Chang K, Zhang Q, He Y, Zhang P, Yang X, Li L, Li TX. Pipeline Embolization Device for Small and Medium Vertebral Artery Aneurysms: A Multicenter Study. Neurosurgery. 2023 May 1;92(5):971-978. doi: 10.1227/neu.0000000000002319. Epub 2022 Dec 29.
- Results Fargen KM, Hoh BL, Welch BG, Pride GL, Lanzino G, Boulos AS, Carpenter JS, Rai A, Veznedaroglu E, Ringer A, Rodriguez-Mercado R, Kan P, Siddiqui A, Levy EI, Mocco J. Long-term results of enterprise stent-assisted coiling of cerebral aneurysms. Neurosurgery. 2012 Aug;71(2):239-44; discussion 244. doi: 10.1227/NEU.0b013e3182571953.
- Results Wang J, Vargas J, Spiotta A, Chaudry I, Turner RD, Lena J, Turk A. Stent-assisted coiling of cerebral aneurysms: a single-center clinical and angiographic analysis. J Neurointerv Surg. 2018 Jul;10(7):687-692. doi: 10.1136/neurintsurg-2017-013272. Epub 2017 Nov 16.
- Results Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, Braun LT, de Ferranti S, Faiella-Tommasino J, Forman DE, Goldberg R, Heidenreich PA, Hlatky MA, Jones DW, Lloyd-Jones D, Lopez-Pajares N, Ndumele CE, Orringer CE, Peralta CA, Saseen JJ, Smith SC Jr, Sperling L, Virani SS, Yeboah J. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Jun 18;139(25):e1046-e1081. doi: 10.1161/CIR.0000000000000624. Epub 2018 Nov 10. No abstract available.
- Results Mach F, Baigent C, Catapano AL, Koskinas KC, Casula M, Badimon L, Chapman MJ, De Backer GG, Delgado V, Ference BA, Graham IM, Halliday A, Landmesser U, Mihaylova B, Pedersen TR, Riccardi G, Richter DJ, Sabatine MS, Taskinen MR, Tokgozoglu L, Wiklund O; ESC Scientific Document Group. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. Eur Heart J. 2020 Jan 1;41(1):111-188. doi: 10.1093/eurheartj/ehz455. No abstract available.
- Results Dawson LP, Lum M, Nerleker N, Nicholls SJ, Layland J. Coronary Atherosclerotic Plaque Regression: JACC State-of-the-Art Review. J Am Coll Cardiol. 2022 Jan 4;79(1):66-82. doi: 10.1016/j.jacc.2021.10.035.
- Results Diomede L, Albani D, Sottocorno M, Donati MB, Bianchi M, Fruscella P, Salmona M. In vivo anti-inflammatory effect of statins is mediated by nonsterol mevalonate products. Arterioscler Thromb Vasc Biol. 2001 Aug;21(8):1327-32. doi: 10.1161/hq0801.094222.
- Results Wagner AH, Kohler T, Ruckschloss U, Just I, Hecker M. Improvement of nitric oxide-dependent vasodilatation by HMG-CoA reductase inhibitors through attenuation of endothelial superoxide anion formation. Arterioscler Thromb Vasc Biol. 2000 Jan;20(1):61-9. doi: 10.1161/01.atv.20.1.61.
- Results Qiao L, Wang S, Jia Q, Bian J, Fan Y, Xu X. Clinical efficacy and safety of statin treatment after carotid artery stenting. Artif Cells Nanomed Biotechnol. 2019 Dec;47(1):3110-3115. doi: 10.1080/21691401.2019.1645149.
- Results Tentzeris I, Rohla M, Jarai R, Farhan S, Freynhofer MK, Unger G, Nurnberg M, Geppert A, Wessely E, Wojta J, Huber K. Influence of high-dose highly efficient statins on short-term mortality in patients undergoing percutaneous coronary intervention with stenting for acute coronary syndromes. Am J Cardiol. 2014 Apr 1;113(7):1099-104. doi: 10.1016/j.amjcard.2013.12.012. Epub 2014 Jan 14.
- Results Lilja F, Wanhainen A, Mani K. Statin therapy after elective abdominal aortic aneurysm repair improves long-term survival. Br J Surg. 2024 Jan 3;111(1):znad383. doi: 10.1093/bjs/znad383.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atorvastatin | Small molecule | 20 mg | Oral |