Tirofiban for the Prevention of Neurological Deterioration in Acute Ischemic Stroke (TREND)

July 16, 2022 updated by: Ji Xunming,MD,PhD, Capital Medical University

Safety and Efficacy of Tirofiban in Preventing Neurological Deterioration of Patients With Acute Ischemic Stroke: A Randomized Controlled Trial

Currently, dual antiplatelet therapy with aspirin and clopidogrel (with loading doses) is widely used for patients with acute ischemic stroke. However, immediate, potent and reversible inhibition of platelet aggregation is not possible. Additionally, more than 5% patients have aspirin resistance and more than 15% patients have clopidogrel resistance. Therefore, an intravenously administered GPIIb/IIIa receptor inhibitor (Tirofiban) receptor blocker with fast onset and offset of actions will provide more desired antiplatelet effects in the setting of acute ischemic stroke, especially in patients with high risk of neurological deterioration. This study will measure the anti-platelet effects of Tirofiban in patients with acute ischemic stroke who had high risk of neurological deterioration.

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.

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 (Anticipated)

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.
420

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 2
  • 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

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100053
        • Recruiting
        • Xuanwu Hospital, Capital Medical University
        • Contact:
          • Qingfeng Ma, M.D.
        • Contact:
          • Wenbo Zhao, M.D.
        • Principal Investigator:
          • Qingfeng Ma
      • Beijing, Beijing, China
        • Not yet recruiting
        • Beijing Luhe Hospital, Capital Medical University
        • Contact:
          • Huishan Du, M.D.
        • Contact:
          • Xiaokun Geng, M.D.
    • Henan
      • Luoyang, Henan, China
        • Not yet recruiting
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Contact:
          • Junqiang Yan, M.D.
      • Nanyang, Henan, China
        • Recruiting
        • Nanyang Central Hospital
        • Contact:
          • Changming Wen, M.D.
      • Nanyang, Henan, China
        • Recruiting
        • Nanyang Second General Hospital
        • Contact:
          • Jinhui Qin, M.D.
      • Zhengzhou, Henan, China
        • Not yet recruiting
        • Henan Provincial People's Hospital
        • Contact:
          • Ziliang Wang, M.D.
      • Zhengzhou, Henan, China
        • Not yet recruiting
        • First Affiliated Hospital of Zhengzhou University
        • Contact:
          • Yuming Xu
    • Hubei
      • Wuhan, Hubei, China
        • Active, not recruiting
        • The Third People's Hospital of Hubei Province
    • Hunan
      • Changsha, Hunan, China
        • Not yet recruiting
        • Hunan Provincial People's Hospital
        • Contact:
          • Xiaoping Gao, M.D.
    • Inner Mongolia Autonomous Region
      • Baotou, Inner Mongolia Autonomous Region, China
        • Recruiting
        • Sinapharm North Hospital
        • Contact:
          • Lifei Xing, M.D.
      • Ordos, Inner Mongolia Autonomous Region, China
        • Recruiting
        • Ordos Central Hospital
        • Contact:
          • Xiaojun Hao
      • Tongliao, Inner Mongolia Autonomous Region, China
        • Recruiting
        • Tongliao City Hosptial
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Not yet recruiting
        • Nanjing Drum Tower Hospital
        • Contact:
          • Yu Xu, M.D.
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Active, not recruiting
        • Jiangxi Provincial People's Hospital
    • Shandong
      • Jinan, Shandong, China
        • Not yet recruiting
        • Shandong Provincial Hospital
        • Contact:
          • Qinjian Sun, M.D.
      • Jinan, Shandong, China
        • Active, not recruiting
        • Shandong Provincial Qianfoshan Hospital
    • Sichuan
      • Chengdu, Sichuan, China
        • Not yet recruiting
        • West China Hospital of Sichuan University
        • Contact:
          • Bo Wu, M.D.
    • Tianjin
      • Tianjin, Tianjin, China
        • Recruiting
        • Beichen Hospital of Traditional Chinese Medicine
        • Contact:
          • Ruixian Wang, M.D.
      • Tianjin, Tianjin, China
        • Active, not recruiting
        • TEDA Hospital

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Acute ischemic stroke with 24 hours of symptom onset.
  2. NIHSS≥4 and ≤20 points, and the paralyzed limbs is able to actively move the muscle (standardized motor examination rating scale of 2 or much higher).
  3. Age 18-80 years old.
  4. Informed consent obtained from patient or acceptable patient's surrogate.

Exclusion Criteria:

  1. Treated with intravenous or endovascular thrombectomy for the indexed acute ischemic stroke.
  2. Acute ischemic stroke caused by determined or suspected cardioembolism.
  3. Acute ischemic stroke caused by other determined caused, including moyamoya disease, artery dissection, arteritis, and etc.
  4. Pre-stroke mRS ≥2 or the paralyzed limbs are dyskinesia before stroke.
  5. Known hematochezia, gastrointestinal bleeding and any other bleeding.
  6. Allergy to tirofiban or its solvents.
  7. Patients suffered from severe diseases, including malignant tumor, liver cirrhosis, kidney failure, congestive heart failure, and etc.
  8. Gastrointestinal or genitourinary tract bleeding within 1 years.
  9. Determined coagulation disorders, platelet dysfunction, or platelet count <100*109/L.
  10. Major surgical operation or severe trauma within 1 month.
  11. Hemorrhagic retinopathy.
  12. Chronic hemodialysis.
  13. Uncontrolled hypertension with systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg.
  14. Acute pericarditis.
  15. Other conditions that determined by the investigators.

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: Single

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+Oral antiplatelet therapy
Patients will receive Tirofiban in the first 72 hours and bridge to oral antiplatelet therapy thereafter.
Drug: Tirofiban Hydrochloride
Tirofiban will use a loading dose, 0.4 μg/kg/min × 30 minutes, then 0.1μg/kg/min infusion for 71.5 hours.
Drug: Oral antiplatelet
Aspirin, clopidogrel or other antiplatelet drugs. Loading dose will be considered if the patients is not on antiplatelet therapy.
Active Comparator: Oral antiplatelet therapy
Patients will receive oral antiplatelet therapy alone.
Drug: Oral antiplatelet
Aspirin, clopidogrel or other antiplatelet drugs. Loading dose will be considered if the patients is not on antiplatelet therapy.

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
Number of patients with a change in NIHSS by ≥ 4 points compared to enrollment NIHSS.
Time Frame: Within 72 hours of intervention.
National Health Institute Stroke Scale (NIHSS): stroke symptom severity scale with a range of 0-42. Higher score means more severe stroke symptoms.
Within 72 hours of intervention.

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
Change of the NIHSS
Time Frame: 0-30 days of intervention.
National Health Institute Stroke Scale (NIHSS): stroke symptom severity scale with a range of 0-42. Higher score means more severe stroke symptoms.
0-30 days of intervention.
Change of the Scandinavian Stroke Scale
Time Frame: 0-30 days of intervention.
Scandinavian Stroke Scale (SSS): stroke symptom severity scale with a range of 0-58. Lower score means more severe stroke symptoms.
0-30 days of intervention.
The severity of global disability at 90 days, as assessed by modified Rankin scale (mRS).
Time Frame: 0-90 days.
The mRS is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranging from 0 (no symptom) to 5 (severe disability) and 6 (death).
0-90 days.
Rate of symptomatic intracerebral hemorrhage.
Time Frame: 0-90 days
0-90 days
Number of Participants experienced adverse events
Time Frame: 0-90 days.
0-90 days.

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.
Capital Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
September 12, 2020

Primary Completion (Anticipated)

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, 2022

Study Completion (Anticipated)

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, 2023

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).
July 25, 2020

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.
July 25, 2020

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.
July 29, 2020

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.
July 19, 2022

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.
July 16, 2022

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.
July 1, 2022

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.
  • Trend

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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