Early Antiplatelet Administration After Intravenous Thrombolysis for Acute Ischemic Stroke (TREND-IVT) (TREND-IVT)

Safety and Efficacy of Treatment With Early Antiplatelet Administration After Intravenous Thrombolysis for Acute Ischemic Stroke (TREND-IVT): A Multicenter, Randomized, Placebo-controlled, Clinical Trial

Stroke is the second leading cause of death worldwide, and ischemic stroke is the most frequent type. Intravenous thrombolysis with recombinant tissue plasminogen activator within 4.5 hours of symptom onset is the most effective therapy for patients with acute ischemic stroke. However, ischemic stroke progression and early reocclusion are not an uncommon phenomenon in patients after intravenous thrombolysis, resulting in neurological deterioration, which is associated with unfavorable functional outcomes. The underlying mechanism mainly involves the augmented platelet activation, triggered by the activated coagulation cascade during thrombolysis, which peaks within 2 hours of initiating rt-PA administration. Therefore, early antiplatelet therapy following intravenous thrombolysis represents a promising therapeutic approach to prevent neurological deterioration and improve the functional outcome of patients treated with intravenous thrombolysis.

Currently, guidelines recommend initiating antiplatelet therapy 24 hours after intravenous thrombolysis due to the potential risk of increased bleeding. The safety and efficacy of early antiplatelet treatment following intravenous thrombolysis in patients with acute ischemic stroke remain clear.

The study aims to test the hypothesis that in patients with acute ischemic stroke treated with intravenous thrombolysis, early administration of oral aspirin will improve functional outcomes without increasing the risk of intracranial hemorrhage.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Infarction; Acute Ischemic Stroke
• Intervention / Treatment: Drug: Aspirin; Other: Best medical management; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 1184
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: XunMing Ji, MD, PD; Phone Number: 010-8319-9439; Email: jixm@ccmu.edu.cn
• Study Contact Backup: Name: Wenbo Zhao, MD, PD; Phone Number: 010-8319-9048; Email: zhaowb@xwh.ccmu.edu.cn

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China, 233000
      • Recruiting
      • The Third the People's Hospital of Bengbu
      • Contact: Bin Ye, M.D.
    • Suzhou, Anhui, China, 234000
      • Recruiting
      • Suzhou Municipal Hospital
      • Contact: Lei Zhang
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100053
      • Recruiting
      • Xuanwu Hospital, Capital Medical University
      • Contact: Wenbo Zhao, M.D.; Phone Number: +86-10-8319-9439; Email: zhaowb@xwh.ccmu.edu.cn
    • Haidian, Beijing Municipality, China, 100049
      • Recruiting
      • Aerospace central hospital
      • Contact: Peifu Wang
    • Pinggu, Beijing Municipality, China, 101200
      • Recruiting
      • Beijing Pinggu District Hospital
      • Contact: Yifei Cheng
    • Tongzhou, Beijing Municipality, China, 101149
      • Recruiting
      • Beijing Luhe Hospital Affiliated to Capital Medical University
      • Contact: Lipeng Cai
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Recruiting
      • Fujian university affiliated provincial hospital
      • Contact: Yingchao He
    • Xiamen, Fujian, China, 361003
      • Recruiting
      • The First Affiliated Hospital of Xiamen University
      • Contact: Yihong Zhan, M.D.
    • Xiamen, Fujian, China, 361020
      • Not yet recruiting
      • Xiamen Xinglin hospital
      • Contact: Caitang Wu, M.D.
    • Zhangzhou, Fujian, China, 363000
      • Recruiting
      • Zhangzhou Hospital of Fujian Province
      • Contact: Tingyu Yi
  • Guangdong
    • Guangzhou, Guangdong, China, 510180
      • Not yet recruiting
      • Brain Hospital Affiliated to Guangzhou Medical University
      • Contact: Lixuan Zhan, M.D.
  • Guangxi
    • Guigang, Guangxi, China, 537100
      • Recruiting
      • Guigang people's hospitalv
      • Contact: Xinming Li
    • Wuzhou, Guangxi, China, 543002
      • Recruiting
      • Wuzhou Red Cross Hospital
      • Contact: Xuan Chen, M.D.
  • Guizhou
    • Kaili, Guizhou, China, 556099
      • Recruiting
      • The Second Affiliated Hospital of Guizhou Medical University
      • Contact: Changsong Wu, M.D.
  • Hainan
    • Haikou, Hainan, China, 570145
      • Recruiting
      • The Second Affiliated Hospital of Hainan Medical University
      • Contact: Bin Liu
  • Hebei
    • Cangzhou, Hebei, China, 061001
      • Recruiting
      • Cangzhou combination of Chinese traditional and western medicine hospital
      • Contact: Yonglin Shan
    • Cangzhou, Hebei, China, 061012
      • Recruiting
      • Cangzhou Central Hospital
      • Contact: Zhen Hong, M.D.
    • Cangzhou, Hebei, China, 062450
      • Recruiting
      • Hejian city People's Hospital
      • Contact: Lixin Wu
    • Handan, Hebei, China, 056001
      • Recruiting
      • Handan Central Hospital
      • Contact: Shejun Feng
    • Handan, Hebei, China, 056002
      • Recruiting
      • Handan First Hospital
      • Contact: Liping Cheng
  • Heilongjiang
    • Qiqihar, Heilongjiang, China, 161005
      • Recruiting
      • The First Hospital of Qiqihar
      • Contact: Chenghe Sun, M.D.
  • Henan
    • Anyang, Henan, China, 456400
      • Recruiting
      • Hua county People's Hospital
      • Contact: Hongling Guo
    • Hebi, Henan, China, 458030
      • Recruiting
      • Jun County People's Hospital
      • Contact: Beihai Jiang
    • Jiangzuo, Henan, China, 454001
      • Recruiting
      • Jiaozuo Second People's Hospital
      • Contact: Bo LI
    • Luoyang, Henan, China, 471900
      • Recruiting
      • Luoyang Yanshi People's Hospital
      • Contact: Yang Zhou, M.D.
    • Luoyang, Henan, China, 471000
      • Recruiting
      • First People's Hospital of Luoyang
      • Contact: Jinfeng Shi
    • Nanyang, Henan, China, 473010
      • Not yet recruiting
      • Nanyang Nanshi Hospital
      • Contact: Junfeng Shi, M.D.
    • Sanmenxia, Henan, China, 472000
      • Not yet recruiting
      • Huanghe Sanmenxia hospital
      • Contact: Meng Xue, M.D.
    • Shangqiu, Henan, China, 476100
      • Recruiting
      • Shangqiu First People's Hospital
      • Contact: Hong Yang
    • Shangqiu, Henan, China, 476000
      • Recruiting
      • Shangqiu Third People's Hospital
      • Contact: Yaping Jing
    • Shangqucun, Henan, China, 476700
      • Recruiting
      • Ningling County People's Hospital
      • Contact: Zhixiang Sui
    • Zhoukou, Henan, China, 466000
      • Recruiting
      • Xihua People's Hospital
      • Contact: Chaoqun Li, M.D.
    • Zhoukou, Henan, China, 477200
      • Recruiting
      • Luyi county people's hospital
      • Contact: Hao Liang
    • Zhumadian, Henan, China, 463000
      • Recruiting
      • Zhumadian Central Hospital
      • Contact: Ligong Gao
  • Hubei
    • Hainan, Hubei, China, 430033
      • Recruiting
      • The Third People's Hospital of Hubei Province
      • Contact: Fangyan Gong
  • Hunan
    • Changde, Hunan, China, 415000
      • Recruiting
      • The First People's Hospital of Changde City
      • Contact: Jun Wen
    • Changde, Hunan, China, 415099
      • Not yet recruiting
      • Changde Taoyuan County People's Hospital
      • Contact: Hui Tan, M.D.
    • Chenzhou, Hunan, China, 424499
      • Not yet recruiting
      • Chenzhou First People's Hospital
      • Contact: Ganghua Feng, M.D.
    • Guankou, Hunan, China, 410300
      • Recruiting
      • Liuyang Jili Hospital
      • Contact: Yong He, M.D.
    • Xiangtan, Hunan, China, 411100
      • Recruiting
      • Xiangtan Central Hospital
      • Contact: Yong Liang, M.D.
    • Zhuzhou, Hunan, China, 412007
      • Recruiting
      • ZhuZhou Central Hospital
      • Contact: Zhen Zhao, M.D.
  • Inner Mongolia
    • Tongliao, Inner Mongolia, China, 028007
      • Recruiting
      • Affiliated Hospital of Inner Mongolia University for the Nationalities
      • Contact: Yaoming Xu, M.D.
    • Ulanqab, Inner Mongolia, China, 012000
      • Recruiting
      • Ulanqab Central Hospital
      • Contact: Shuzhen Gong, M.D.
    • Zhalantun, Inner Mongolia, China, 162650
      • Recruiting
      • Zha Lan Tun Shi Zhong Meng Yi Yuan
      • Contact: Chengyan Yang, M.D.
  • Jiangsu
    • Suzhou, Jiangsu, China, 215004
      • Recruiting
      • The First Affiliated Hospital of Soochow University
      • Contact: Qi Fang
    • Suzhou, Jiangsu, China, 215021
      • Recruiting
      • The Fourth Affiliated Hospital of Soochow University
      • Contact: Qi Fang
  • Jiangxi
    • Jingdezhen, Jiangxi, China, 333000
      • Recruiting
      • Jingdezhen No.1 People's Hospital
      • Contact: Mingchao Wu, M.D.
    • Nanchang, Jiangxi, China, 330008
      • Recruiting
      • The Second Affiliated Hospital of Nanchang University
      • Contact: Jianglong Tu, M.D.
  • Liaoning
    • Anshan, Liaoning, China, 114000
      • Not yet recruiting
      • Anshan Changda Hospital
      • Contact: Fan Zhang, M.D.
    • Dandong, Liaoning, China, 118300
      • Recruiting
      • Donggang city Central Hospital
      • Contact: Jing Li
    • Fushun, Liaoning, China
      • Not yet recruiting
      • Fushun Mining Bureau General Hospital
      • Contact: Hong 113012 Zhang, M.D.
  • Neimeng
    • Neimeng, Neimeng, China, 010200
      • Recruiting
      • Togtoh county hospital
      • Contact: Meixiu Hao
  • Shandong
    • Dongying, Shandong, China, 257034
      • Recruiting
      • Shengli Oilfield Central Hospital
      • Contact: Ye Lang
    • Dongying, Shandong, China, 257029
      • Recruiting
      • Dongying People's Hospital
      • Contact: Wenjun Zhang
    • Jinan, Shandong, China, 250014
      • Recruiting
      • Shandong province qianfoshan hospital
      • Contact: Weili Li
    • Jinan, Shandong, China, 250101
      • Recruiting
      • Jinan Third People's Hospital
      • Contact: Peng Guo, M.D.
    • Liaocheng, Shandong, China, 252000
      • Recruiting
      • Liaocheng People's Hospital
      • Contact: Weidong Liu
    • Liaocheng, Shandong, China, 252000
      • Recruiting
      • The Third People Hospital in Liaocheng
      • Contact: Ke Diao, M.D.
    • Liaocheng, Shandong, China, 252800
      • Recruiting
      • Gaotang county people's hospital
      • Contact: Huqing Li, M.D.
    • Qingdao, Shandong, China, 266700
      • Recruiting
      • Pingdu city traditional Chinese medicine hospital
      • Contact: Hong Sui
    • Rizhao, Shandong, China, 276500
      • Recruiting
      • Juxian county people's hospital
      • Contact: Jiawen Sun
    • Rizhao, Shandong, China, 276800
      • Recruiting
      • Rizhao traditional Chinese medicine hospital
      • Contact: Lei Mu
    • Taian, Shandong, China, 271614
      • Recruiting
      • Shandong health group feicheng hospital
      • Contact: Youfeng Si
    • Weihai, Shandong, China, 264200
      • Recruiting
      • Weihai Municipal Hospital
      • Contact: Weibin Zhong, M.D.
    • Zibo, Shandong, China, 255020
      • Not yet recruiting
      • Zibo Central Hospital
      • Contact: Chao Wang, M.D.
  • Shanxi
    • Weinan, Shanxi, China, 714000
      • Not yet recruiting
      • Weinan Central Hospital
      • Contact: Yahong Guo, M.D.
  • Shenzhen
    • Shenzhen, Shenzhen, China, 518035
      • Recruiting
      • Shenzhen Second People's Hospital
      • Contact: Pengcheng Fu
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • Chengdu Second People's Hospital
      • Contact: Changchuan Wu
    • Ya'an, Sichuan, China, 625000
      • Recruiting
      • Ya 'an People's Hospital
      • Contact: Jian Wang
  • Xinjiang
    • Shihezi, Xinjiang, China, 832000
      • Recruiting
      • Shihezi City People's Hospital
      • Contact: Feng Chen, M.D.
  • Zhejiang
    • Jiaxing, Zhejiang, China, 314311
      • Recruiting
      • Haiyan People's Hospital
      • Contact: Zhenhua Xi, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥18 years old;
2. Acute ischemic stroke treated with intravenous thrombolysis with alteplase or tenecteplase within 4.5 hours of onset or time last known well, and can receive the study drug treatment within 3 hours of initiating intravenous thrombolysis.
3. Residual NIHSS score > 5 points assessed 1 hour after initiation of intravenous thrombolysis and prior to randomization.
4. Informed consent obtained from patients or an authorized representative.

Exclusion Criteria:

1. Stroke caused by definite large vessel occlusion (including A1/A2 segments of the anterior cerebral artery, M1/M2 segments of the middle cerebral artery, P1/P2 segments of the posterior cerebral artery, intracranial/extracranial segments of the internal carotid artery, basilar artery, and bilateral vertebral artery occlusion) confirmed by vessel imaging (including computed tomography angiography [CTA] or magnetic resonance angiography [MRA]), or scheduled for endovascular treatment (including mechanical thrombectomy, intra-arterial thrombolysis, and angioplasty).
2. Intracranial hemorrhage confirmed by imaging post-thrombolysis.
3. Definite or suspected cardioembolic stroke.
4. Stroke caused by other determined causes, including nonatherosclerotic vasculopathies (moyamoya disease, artery dissection, arteritis), hypercoagulable states, or hematological disorders.
5. Use of antiplatelet therapy within one week prior to stroke onset, novel anticoagulant drugs within 48 hours prior to stroke onset, or treatment with warfarin with an international normalized ratio (INR)>1.7.
6. Prior history of moderate or severe ischemic stroke events with residual neurological disability.
7. Pre-stroke mRS score > 1.
8. Severe consciousness disturbance with NIHSS item 1a (level of consciousness) ≥ 2 points.
9. Post-thrombolysis imaging indicates an infarct area larger than 1/2 responsible artery supply area.
10. Known contraindications for antiplatelet therapy, such as coagulation disorders, or systemic bleeding
11. History of aspirin allergy.
12. Anticipated indications for anticoagulant therapy during the study period (e.g., atrial fibrillation, mechanical heart valve, deep vein thrombosis, pulmonary embolism, antiphospholipid syndrome, hypercoagulable state)
13. Presence of malignant tumors, chronic hemodialysis, severe renal insufficiency (GFR < 30 mL/min or serum creatinine > 220 μmol/L [2.5 mg/dL]), severe hepatic insufficiency (serum alanine aminotransferase [ALT] >2 times the upper limit of normal, or serum aspartate aminotransferase [AST] >2 times the upper limit of normal), severe heart failure (New York Heart Association [NYHA] Functional Classification Class III or IV)
14. Severe non-cardiovascular complications with an expected survival of less than 6 months.
15. Unavailability for follow-up.
16. Presence of dementia, psychiatric disorders, or other known neurological conditions that complicate follow-up.
17. Current participation in another therapeutic study with ongoing treatment and follow-up.
18. Other conditions that make the patient unsuitable for participation in the study as determined by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional group; Patients in the interventional group will receive early antiplatelet treatment with oral aspirin within 3 hours of initiating intravenous thrombolysis. In addition, the best medical management will be administered according to the guidelines.	Drug: Aspirin; Patients in the interventional group will chew 300mg of aspirin enteric-coated tablets as soon as possible after randomization. If swallowing difficulties arise, the tablets can be crushed and administered via a nasogastric tube.; Other: Best medical management; Patients in both groups will receive the best medical management according to the guidelines.
Placebo Comparator: Control group; Patients in the control group will receive placebos within 3 hours of initiating intravenous thrombolysis. In addition, the best medical management will be administered according to the guidelines.	Other: Best medical management; Patients in both groups will receive the best medical management according to the guidelines.; Drug: Placebo; Patients in the control group will chew 300mg of placebos as soon as possible after randomization. If swallowing difficulties arise, the placebo can be crushed and administered via a nasogastric tube.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of patients with a modified Rankin scale (mRS) score of 0-1 at 90-day follow up.	The mRS ranges from 0 to 6, with higher scores indicating a worse outcome. The primary outcome measure is based on the mRS score, which is dichotomized to define the excellent functional outcome as mRS score of 0-1 at 90-days follow up.	Ninety days after stroke.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of patients with a modified Rankin scale (mRS) score of 0-1 at 30-day follow up.	The mRS ranges from 0 to 6, with higher scores indicating a worse outcome. The primary outcome measure is based on the mRS score, which is dichotomized to define the excellent functional outcome as mRS score of 0-1 at 30-days follow up.	Thirty days after stroke.
The proportion of patients with a modified Rankin scale (mRS) score of 0-2 at 90-day follow up.	The mRS ranges from 0 to 6, with higher scores indicating a worse outcome. Functional independence is defined as mRS of 0-2.	Ninety days after stroke.
The shift analysis in the 90-day modified Rankin scale (mRS) score.	The mRS ranges from 0 to 6, with higher scores indicating a worse outcome.	Ninety days after stroke.
The proportion of patients achieving neurological improvement.	Neurological improvement is defined as a decrease of ≥2 points in the NIHSS score at 48 hours of randomization compared to baseline assessment.	Within 48 hours after stroke.
The proportion of patients experiencing early neurological deterioration.	Early neurological deterioration is defined as an increase of ≥4 points in the NIHSS score within 24 hours of randomization compared with the minimum NIHSS score before deterioration.	Within 24 hours after stroke.
The changes in the NIHSS score at 24 hours, 48 hours, and 7 days of enrollment as compared with the baseline.	The NIHSS ranges from 0 to 42 points, with higher scores indicating worse neurological deficits.	Within 7 days after stroke.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of symptomatic intracranial hemorrhage.	Symptomatic intracranial hemorrhage is defined as the demonstration of hemorrhage within brain parenchyma on head imaging leading to an increase of at least 4 points in the NIHSS score, according to the criteria of the European Cooperative Acute Stroke Study III (ECASS III).	Within 48 hours after stroke.
Incidence of any intracranial hemorrhage.	Any intracranial hemorrhage is defined as the demonstration of hemorrhage within brain parenchyma on head imaging, according to the criteria of the ECASS III.	Within 48 hours after stroke.
Incidence of systemic hemorrhage.	The incidence of systemic hemorrhage at any time from randomization through day 90, according to the criteria of the GUSTO.	Within 90 days after stroke.
Incidence of recurrent stroke or other vascular events.	The incidence of recurrent stroke or other vascular events (including hemorrhagic and ischemic stroke, myocardial infarction, and cardiovascular death) within 90 days of randomization.	Within 90 days after stroke.
All-cause death.	The incidence of death events at any time from randomization through day 90.	Within 90 days after stroke.
Incidence of Adverse Events/Serious Adverse Events	The incidence of other adverse events and serious adverse events at any time from randomization through day 90.	Within 90 days after stroke.

Collaborators and Investigators

• Sponsor: Capital Medical University

Publications and helpful links

General Publications

• Wu C, Sun C, Wang L, Lian Y, Xie N, Huang S, Zhao W, Ren M, Wu D, Ding J, Song H, Wang Y, Ma Q, Ji X. Low-Dose Tirofiban Treatment Improves Neurological Deterioration Outcome After Intravenous Thrombolysis. Stroke. 2019 Dec;50(12):3481-3487. doi: 10.1161/STROKEAHA.119.026240. Epub 2019 Oct 1.
• Zinkstok SM, Roos YB; ARTIS investigators. Early administration of aspirin in patients treated with alteplase for acute ischaemic stroke: a randomised controlled trial. Lancet. 2012 Aug 25;380(9843):731-7. doi: 10.1016/S0140-6736(12)60949-0. Epub 2012 Jun 28.
• Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2019 Dec;50(12):e344-e418. doi: 10.1161/STR.0000000000000211. Epub 2019 Oct 30.
• Demaerschalk BM, Kleindorfer DO, Adeoye OM, Demchuk AM, Fugate JE, Grotta JC, Khalessi AA, Levy EI, Palesch YY, Prabhakaran S, Saposnik G, Saver JL, Smith EE; American Heart Association Stroke Council and Council on Epidemiology and Prevention. Scientific Rationale for the Inclusion and Exclusion Criteria for Intravenous Alteplase in Acute Ischemic Stroke: A Statement for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2016 Feb;47(2):581-641. doi: 10.1161/STR.0000000000000086. Epub 2015 Dec 22.
• Zhao W, Li S, Li C, Wu C, Wang J, Xing L, Wan Y, Qin J, Xu Y, Wang R, Wen C, Wang A, Liu L, Wang J, Song H, Feng W, Ma Q, Ji X; TREND Investigators. Effects of Tirofiban on Neurological Deterioration in Patients With Acute Ischemic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2024 Jun 1;81(6):594-602. doi: 10.1001/jamaneurol.2024.0868.

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: August 3, 2024
• First Submitted That Met QC Criteria: August 8, 2024
• First Posted (Actual): August 12, 2024

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 14, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Aspirin; Acute ischemic stroke; Intravenous thrombolysis; Early neurological deterioration
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Brain Infarction; Brain Ischemia; Infarction; Necrosis; Ischemia; Stroke; Pathological Conditions, Signs and Symptoms; Ischemic Stroke; Cerebral Infarction; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Salicylates; Hydroxybenzoates; Aspirin
• Other Study ID Numbers: TREND-IVT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No