Early Administration of Tirofiban in Patients Treated With Tenecteplase for Acute Ischemic Stroke (INSTANT)

December 17, 2025 updated by: Jian Zhang, MD, Second Affiliated Hospital of Guangxi Medical University

Safety and Efficacy of Early Administration of Tirofiban in Patients Treated With Tenecteplase for Acute Ischemic Stroke

The purpose of this study is to assess the safety and efficacy of early administration of tirofiban in patients treated with tenecteplase for acute ischemic stroke.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Intravenous thrombolysis with alteplase is recommended in treatment guidelines for patients with acute ischemic stroke. Previous studies showed that intravenous tenecteplase (0.25 mg/kg) is a reasonable alternative to alteplase for all patients presenting with acute ischemic stroke who meet standard criteria for thrombolysis. After thrombolysis-induced recanalisation, reocclusion occurs in 14-34% of patients, probably because of platelet activation. Early administration of antiplatelet therapy after intravenous thrombolysis could reduce the risk of reocclusion and improve outcome. The purpose of this study is to assess the safety and efficacy of early administration of tirofiban in patients treated with tenecteplase for acute ischemic stroke.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
348

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Guoyong Zeng, MD
  • Phone Number: +8613507079530
  • Email: hsyygy@163.com

Study Locations

  • China
    • Anhui
      • Chuzhou, Anhui, China
        • Recruiting
        • Mingguang People's Hospital
        • Contact:
          • Lei Chen
        • Contact:
          • Zongliang Li,
    • Fujian
      • Longyan, Fujian, China
        • Recruiting
        • Longyan People´s Hospital, Longyan City
        • Contact:
          • Yuqin Deng
    • Guangxi
      • Nanning, Guangxi, China
        • Recruiting
        • The Second Affiliated Hospital of Guangxi Medical University
        • Contact:
          • Deyan Kong, MD
    • Hubei
      • Huanggang, Hubei, China
        • Recruiting
        • Huangmei People's Hospital
        • Contact:
          • Junfeng Shi
        • Contact:
          • Hongtao Huo
      • Yichang, Hubei, China
        • Recruiting
        • Yiling People's Hospital of Yichang city
        • Contact:
          • Hailong Xu
        • Contact:
          • Zhenxing Liu
    • Hunan
      • Huaihua, Hunan, China
        • Recruiting
        • Hunan Xupu Chengnan Hospital
        • Contact:
          • Bin Zhang
        • Contact:
          • Bo Wang
      • Shaoyang, Hunan, China
        • Recruiting
        • People's Hospital Of Shaodong
        • Contact:
          • Limin Shen
      • Xiangtan, Hunan, China
        • Recruiting
        • Shaoshan People's Hospital
        • Contact:
          • Zhenhua Xiao
        • Contact:
          • Shuai Zhao
      • Xiangtan, Hunan, China
        • Recruiting
        • Xiangtan Central Hospitall
        • Contact:
          • Guangxiong Yuan
        • Contact:
          • Junxiong Wu
      • Yueyang, Hunan, China
        • Recruiting
        • Hunan University of Medicine Affiliated Pingjiang Hospital
        • Contact:
          • Xiang Zeng
        • Contact:
          • Sire Li
    • Jiangxi
      • Ganzhou, Jiangxi, China, 341000
        • Recruiting
        • Ganzhou People's Hospital
        • Contact:
        • Contact:
          • Fan Zhang
          • Phone Number: +8618970148470
      • Ganzhou, Jiangxi, China, 341000
        • Recruiting
        • People's Hospital of Dayu County
        • Contact:
          • Huashi Liu,
        • Contact:
          • Yongfang Deng
      • Ganzhou, Jiangxi, China, 341000
        • Recruiting
        • People's Hospital of Ganxian District
        • Contact:
          • Weihua Hu,
        • Contact:
          • Jianyong Chen
      • Ganzhou, Jiangxi, China, 341000
        • Recruiting
        • People's Hospital of Quannan County
        • Contact:
          • Qiang Li
        • Contact:
          • Bin Chen
      • Ganzhou, Jiangxi, China, 341000
        • Recruiting
        • People's Hospital of RuiJin City
        • Contact:
          • Ruize Zhou
        • Contact:
          • Xiaomei Lai
      • Ganzhou, Jiangxi, China, 341000
        • Recruiting
        • People's Hospital of Shangyou County
        • Contact:
          • Yi Yin
        • Contact:
          • Daofei Liu
      • Ganzhou, Jiangxi, China, 341000
        • Recruiting
        • People's Hospital of Xinfeng County
        • Contact:
          • Yan Shi
        • Contact:
          • Qing Chen
      • Ganzhou, Jiangxi, China, 341000
        • Recruiting
        • People's Hospital of Xunwu County
        • Contact:
          • Donghuan Mei
        • Contact:
          • Hailin Yan
      • Ganzhou, Jiangxi, China, 341000
        • Recruiting
        • People's Hospital of Yudu County
        • Contact:
          • Zhiyong Xie,
        • Contact:
          • Qingfeng Zeng
      • Ganzhou, Jiangxi, China
        • Recruiting
        • Ganzhou Municipal Hospital
        • Contact:
          • Hongwen Liu
        • Contact:
          • Jiangqiang Lai
      • Ganzhou, Jiangxi, China
        • Recruiting
        • Nankang TCM Hospital
        • Contact:
          • Fangwei Li
        • Contact:
          • Long Gao
      • Ganzhou, Jiangxi, China
        • Recruiting
        • People's Hospital of Anyuan County
        • Contact:
          • Hong Zhang
        • Contact:
          • Xiaobin Zeng
      • Ganzhou, Jiangxi, China
        • Recruiting
        • People's Hospital of Chongyi County
        • Contact:
          • Xunwei Lv,
        • Contact:
          • Huadong Li
      • Ganzhou, Jiangxi, China
        • Recruiting
        • People's Hospital of Shicheng County
        • Contact:
          • Gengxiang Xiao
        • Contact:
          • Longshen Huang
      • Ganzhou, Jiangxi, China
        • Recruiting
        • Second Hospital of Xingguo County
        • Contact:
          • Shanggui Yuan
        • Contact:
          • Yanmao Liu
      • Ganzhou, Jiangxi, China
        • Recruiting
        • Second People's Hospital of Yudu County
        • Contact:
          • Xiaoyu Guan,
        • Contact:
          • Luyang Wang
      • Ganzhou, Jiangxi, China
        • Recruiting
        • The People's Hospital of Ningdu County
        • Contact:
          • Jian Xiao
        • Contact:
          • Hairong Hu,
      • Ganzhou, Jiangxi, China
        • Recruiting
        • Traditional Chinese Medicine Hospital of Xingguo County
        • Contact:
          • Shuiping Liang
        • Contact:
          • Xiankun Yang
      • Ganzhou, Jiangxi, China
        • Recruiting
        • Traditional Chinese Medicine Hospital of Yudu County
        • Contact:
          • Jinchang Tan
        • Contact:
          • Guozhen Liu
      • Jiujiang, Jiangxi, China
        • Recruiting
        • Affiliated Hospital of Jiujiang University
        • Contact:
          • Zhongbin Xia
        • Contact:
          • Ye Liu
      • Ji’an, Jiangxi, China
        • Recruiting
        • Ji'an Central People's Hospital
        • Contact:
          • Yi Chen
      • Ji’an, Jiangxi, China
        • Recruiting
        • People's Hospital of Wan'an county
        • Contact:
          • Bin Liu
        • Contact:
          • Wenbin Qiu
      • Nanchang, Jiangxi, China
        • Recruiting
        • Jiangxi Provincial People's Hospital
        • Contact:
          • Wenfeng Cao
        • Contact:
          • Zhengbing Xiang
      • Yichun, Jiangxi, China
        • Recruiting
        • People's Hospital of Yichun
        • Contact:
          • Ling Gao
        • Contact:
          • Xinbo Deng
      • Yingtan, Jiangxi, China
        • Recruiting
        • Yingtan People's Hospital
        • Contact:
          • Jingjing Liu
        • Contact:
          • Tianpei Li
    • Jilin
      • Songyuan, Jilin, China
        • Recruiting
        • Songyuan Jilin Oilfield Hospital
        • Contact:
          • Ying Jin
        • Contact:
          • Chunying Li
    • Liaoning
      • Dalian, Liaoning, China
        • Recruiting
        • Dalian Municipal Central Hospital
        • Contact:
          • Zhongjun Chen
        • Contact:
          • Manhong zhao
    • Neimenggu
      • Chifeng, Neimenggu, China
        • Recruiting
        • Zhongmeng Hospital of Hexigten Banner
        • Contact:
          • Dan Li
        • Contact:
          • Guozhi Lu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years old;
  2. Within 4-24 hours after intravenous thrombolytic therapy with tenerplase for acute ischemic stroke, there was no significant change in symptoms compared to the baseline (defined as an increase or decrease of 0 or 1 point in the NIHSS score), and neurological function deteriorated (defined as an increase of ≥ 2 in the NIHSS score compared to the baseline) Fluctuations in neurological function (defined as an increase of 4 points or more in the NIHSS score compared to the baseline and then a decrease of 4 points or more);
  3. NIHSS ≥ 4 points before randomization;
  4. The patient or their family members sign a written informed consent form.

Exclusion Criteria:

  1. Intracranial hemorrhage was confirmed by CT or MRI after intravenous thrombolysis and before randomization;
  2. CTA/MRA/DSA showed occlusion of the internal carotid artery, middle cerebral artery M1, M2 or M3 segment, anterior cerebral artery A1, A2 or A3 segment, posterior cerebral artery P1, P2 or P3, vertebral or basilar artery;
  3. Confirmed or suspected cardioembolic stroke mechanisms, including any of the following: documented cardiac sources of thromboembolism: chronic or paroxysmal atrial fibrillation, rheumatic mitral stenosis, prosthetic heart valves, infective endocarditis, intracardiac thrombus or implanted prosthetic material, dilated cardiomyopathy (left ventricular ejection fraction <40%), or spontaneous echo contrast in the left atrium; other laboratory-confirmed embolic sources: patent foramen ovale with concomitant atrial septal aneurysm, or cryptogenic stroke with a CHADS-VASC score ≥ 2 indicating high thromboembolic risk;
  4. Blood platelet count was lower than 100×10^9/L;
  5. Renal insufficiency, glomerular filtration rate < 30 mL/min;
  6. Pregnant or lactating women;
  7. Allergic to tirofiban, nickel, titanium or their alloys;
  8. Prior neurological or psychiatric illness that prevents assessment of neurological function;
  9. Pre-existing bleeding disease, severe heart, liver, or kidney disease, or sepsis;
  10. Brain tumors with a space-occupying effect on imaging (other than micromeningiomas);
  11. Intracranial aneurysm, arteriovenous malformation;
  12. Life expectancy of any advanced disease < 6 months;
  13. Participating in other clinical trials.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tirofiban
Patients are treated with intravenous tenecteplase first, and patients who meet the selection criteria will be randomly assigned to either the tirofiban or placebo group in a 1:1 ratio. Patients assigned to the tirofiban group will be treated with intravenous tirofiban. It is recommended to start treatment as soon as possible (within 10 minutes recommended) after randomization. Tirofiban will be administered at a dose of 0.3 μg per kilogram of body weight per minute for 30 minutes, followed by a continuous infusion of 0.075 μg per kilogram per minute for 47.5h. Aspirin placebo (1 tablet) and/or clopidogrel placebo (1 tablet) will be given orally at 24h after intravenous tenecteplase. Antiplatelet therapy with aspirin (100 mg) and/or clopidogrel (75 mg) will be administered at 44h after randomization until the follow-up period of 90 days.
Drug: Tirofiban Hydrochloride
Patients will receive a continuous intravenous infusion of tirofiban at a dose of 0.3 μg per kilogram of body weight per minute for 30 minutes, followed by a continuous infusion of 0.075 μg per kilogram per minute for 47.5h after start of tenecteplase treatment within 4-24 hours. Aspirin placebo (1 tablet) and/or clopidogrel placebo (1 tablet) will be given orally at 24h after intravenous tenecteplase. Antiplatelet therapy with aspirin (100 mg) and/or clopidogrel (75 mg) will be administered at 44h after randomization until the follow-up period of 90 days.
Placebo Comparator: Placebo
All patients are treated with intravenous tenecteplase first, and patients who meet the selection criteria will be randomly assigned to either the tirofiban or placebo group in a 1:1 ratio. Patients assigned to the placebo group will be treated with intravenous saline. It is recommended to start treatment as soon as possible (within 10 minutes recommended) after randomization. Placebo will be administered at a dose of 0.3 μg per kilogram of body weight per minute for 30 minutes, followed by a continuous infusion of 0.075 μg per kilogram per minute for 47.5h. Aspirin (1 tablet) and/or clopidogrel (1 tablet) will be given orally at 24h after intravenous tenecteplase. Antiplatelet therapy with aspirin (100 mg) and/or clopidogrel (75 mg) will be administered at 44h after randomization until the follow-up period of 90 days.
Drug: Placebo
Patients will receive a continuous intravenous infusion of placebo at a dose of 0.3 μg per kilogram of body weight per minute for 30 minutes, followed by a continuous infusion of 0.075 μg per kilogram per minute for 47.5h after start of tenecteplase treatment within 4-24 hours. Aspirin (1 tablet) and/or clopidogrel (1 tablet) will be given orally at 24h after intravenous tenecteplase. Antiplatelet therapy with aspirin (100 mg) and/or clopidogrel (75 mg) will be administered at 44h after randomization until the follow-up period of 90 days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Excellent functional outcome
Time Frame: 90 days post-randomization
modified Rankin scale score of 0 to 1. modified Rankin scale scores range from 0 to 6, with 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death.
90 days post-randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ordinal degree of disability
Time Frame: 90 days post-randomization
Ordinal degree of disability on the modified Rankin scale score at 90 days (shift analysis)
90 days post-randomization
Functionally independent
Time Frame: 90 days post-randomization
modified Rankin scale score of 0 to 2
90 days post-randomization
Ambulatory or bodily needs capable or better
Time Frame: 90 days post-randomization
modified Rankin scale score of 0 to 3
90 days post-randomization
Early neurologic improvement
Time Frame: 48 hours post-randomization
defined as the National Institutes of Health Stroke Scale score at 48 hours after randomization, is reduced by 30% or more compared to the National Institutes of Health Stroke Scale score at randomization
48 hours post-randomization
Health-related quality of life
Time Frame: 90 days post-randomization
assessed with the European Quality Five Dimensions Five Level scale
90 days post-randomization
Symptomatic intracranial hemorrhage
Time Frame: 48 hours post-randomization
defined as per the Heidelberg bleeding classification
48 hours post-randomization
Radiologic intracranial hemorrhage rate
Time Frame: 48 hours post-randomization
diagnosed with intracranial hemorrhage (including bleeding in brain parenchyma, subarachnoid space, etc.) via radiologic examinations (e.g., computed tomography or magnetic resonance imaging
48 hours post-randomization
Mortality
Time Frame: 90 days post-randomization
The proportion of participants who die from any cause within 90 days after randomization in the study
90 days post-randomization
Incidence of non-hemorrhagic serious adverse events
Time Frame: Within 90 days post-randomization
such as pneumonia, respiratory failure, circulatory failure, cerebral herniation, secondary epilepsy, sepsis, renal failure, acute coronary syndrome, venous thrombosis, etc
Within 90 days post-randomization
Other serious adverse events
Time Frame: Within 90 days post-randomization
Serious adverse events that are not categorized as non-hemorrhagic (as listed in Outcome 10), including any unlisted severe medical events requiring medical intervention or leading to significant clinical deterioration
Within 90 days post-randomization

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ordinal degree of disability
Time Frame: 1 year post-randomization
Ordinal degree of disability on the modified Rankin scale score at 1 year (shift analysis)
1 year post-randomization
Excellent functional status
Time Frame: 1 year post-randomization
modified Rankin scale score 0 to 1 at 1 year
1 year post-randomization
Functionally independent
Time Frame: 1 year post-randomization
modified Rankin scale score 0 to 2 at 1 year
1 year post-randomization
Ambulatory or bodily needs capable or better
Time Frame: 1 year post-randomization
modified Rankin scale score 0 to 3 at 1 year
1 year post-randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital of Guangxi Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ganzhou People's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zhongming Qiu, MD, Sun Yet-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 24, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 3, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SecondAHGuangxiMU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Protocol, Statistical Analysis Plan, and Analytic Code will be shared after approval of a proposal from principal investigator 3 years after the trial results are revealed.

IPD Sharing Time Frame

3 years after the trial results are revealed.

IPD Sharing Access Criteria

After approval of a proposal from principal investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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