Acute Ischemic StrokePhase 3NCT03844594
Eptifibatide in Endovascular Treatment of Acute Ischemic Stroke (EPOCH)
A Phase 3 study testing Eptifibatide Injection in people with Acute Ischemic Stroke, run by Ministry of Science and Technology of the People´s Republic of China at 1 site in China.
Trial summary
The study is a single-arm, open-label, multicenter clinical trial.The primary purpose of this trial is to evaluate the incidence of symptomatic intracranial hemorrhage in patients with acute ischemic stroke within 48 hours after the use of Eptifibatide injection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Eptifibatide Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 6 Apr 2019to 31 Dec 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥18 years.
- Acute ischemic stroke.
- Treated with endovascular treatment, including intra-arterial thrombolysis, mechanical thrombectomy, and angioplasty.
- Written informed consent obtained from patient or patient's legally authorized representative.
Who cannot join
- Failed to vascular recanalization (mTICI≤1).
- Diagnosis of intracranial hemorrhagic disease, such as intracranial hemorrhage, subarachnoid hemorrhage and so on.
- Known coagulopathy, Systemic Bleeding Tendency, or baseline platelet count < 100000/mm3.
- History of chronic hepatopathy, liver and kidney dysfunction, elevating ALT (> 3 times normal upper limit), elevating serum creatinine (> 2 times normal upper limit).
- Patients with severe hypertension (systolic blood pressure > 200mmHg or diastolic blood pressure > 110mmHg).
- Known drug or food allergy.
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- Used other Glycoprotein IIb/IIIa receptor antagonists.
- Contraindications for DSA, severe contrast media allergy or iodine contrast media absolute contraindications.
- Childbearing age women whose pregnancy tests were negative refused to take effective contraception. Pregnant or lactating or positive pregnancy test on admission.
- Incapable to follow this study for mental illness, cognitive or emotional disorder.
- The researchers do not consider the participants appropriate to get into this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070
Zhongrong Miao, MD,Ph.D
About this study
Official title: Safety and Efficacy of Eptifibatide in Endovascular Treatment of Acute Ischemic Stroke: a Single-arm, Open-label, Multicenter Clinical Trial
The study is a single-arm, open-label, multicenter clinical trial.The primary purpose of this trial is to evaluate the incidence of symptomatic intracranial hemorrhage in patients with acute ischemic stroke within 48 hours after the use of Eptifibatide injection. Patients with acute ischemic stroke treated with intravascular thrombolytic therapy, mechanical thrombolysis, angioplasty and so on were treated with Eptifibatide injection on the first day, followed by the second day, the third day, the discharge day and the 90 days.
Read the detailed description
The study is a single-arm, open-label, multicenter clinical trial.A total of 220 patients (Age≥18years) with acute ischemic stroke treated with intravascular thrombolysis, mechanical thrombolysis, angioplasty, etc., were treated with Eptifibatide, providing informed consent and medication.The recommended dose of this study was: first, 135ug / kg was injected intravenously or intraductal (within 5 minutes), followed by continuous intravenous infusion of 0.75 ug / kg / min for 24 h. In special cases, it is up to the operator to decide whether to reinject or increase the dosage according to experience. The maximum dose for the first time was 180ug / kg, if necessary, with a 10-minute interval of intravenously or intraductal injection, and a maximum dose of 180ug / kg, intravenously / intraductal injection of no more than 360ug / kg. Continuous intravenous infusion does not exceed 2ug/kg/ Min. Then the second day, the third day, the discharge and 90 days visit. Follow-up information included vital signs and physical examination, observation of symptomatic intracranial hemorrhage, NIHSS scale, and recording of current drug use by AE,SAE.The trial is anticipated to last from January 2019 to December 2019 with 220 subjects recruited form 15 centers in China. All the related investigative organization and individuals will obey the Declaration of Helsinki and Chinese GCP standard. A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study. The trial has been approved by Institutional Review Board (IRB) and Ethics Committee(EC) in Being Tiantan hospital, Capital Medical University.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Eptifibatide Injection
- Keywords
- Acute Ischemic Stroke, Eptifibatide, Endovascular Treatment, Recovery of Dysfunction
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eptifibatide InjectionDrug
Recommendation: first, intravenously or intraductal injection of 135ug / kg (completed in 5 minutes), followed by continuous intravenous infusion of 0.75ug / kg / min for 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Eptifibatide Drug: Eptifibatide Injection | Experimental | Not described Receives: Drug: Eptifibatide Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic intracranial hemorrhage
Incidence of symptomatic Intracranial Hemorrhage within 48 hours after treatment
Measured: Within 48 hours
Secondary outcomes (12)
Cerebral parenchymal hemorrhage type (PH1) and (PH2)
The incidence of cerebral parenchymal hemorrhage type (PH1) and (PH2) for 48 hours of treatment
Measured: 48 hours
Serious adverse events
Proportion of serious adverse events occurring within 48 hours of treatment
Measured: Within 48 hours
Total death rate
Total death rate within 48 hours of treatment
Measured: Within 48 hours
Adverse events
Proportion of adverse events within 48 hours of treatment
Measured: Within 48 hours
Serious adverse events
Proportion of serious adverse events within 90 days of treatment
Measured: Within 90 days
Total death rate
Total death rate within 90 days of treatment
Measured: Within 90 days
Adverse events
Proportion of adverse events treated within 90 days
Measured: Within 90 days
Vascular recanalization
Proportion of vascular recanalization at the first 24 hours during the therapy
Measured: 24 hours
Favorable clinical outcomes
Proportion of patients achieve favorable clinical outcomes (mRS 0-2) after 90 days of treatment
Measured: 90 days
Neurological recovery
The recovery of neurological deficits assessed by the difference of the 90 days NIHSS to the baseline NIHSS
Measured: 90 days
Recurrent ischemic stroke
Proportion of recurrent ischemic stroke after 90 days of treatment
Measured: 90 days
Combined vascular events
Proportion of combined vascular events (recurrent ischemic stroke, myocardial infarction and vascular death) at 90 days of treatment
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start6 Apr 2019
- Primary completion30 Jun 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Science and Technology of the People´s Republic of China
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zhongrong Miao, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844594
- Sponsor's protocol ID
- 2019EPOCH19011912
- Status last verified
- Jun 2019
- First submitted
- 14 Feb 2019
- Last updated
- 18 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ma G, Sun X, Cheng H, Burgin WS, Luo W, Jia W, Liu Y, He W, Geng X, Zhu L, Chen X, Shi H, Xu H, Zhang L, Wang A, Mo D, Ma N, Gao F, Song L, Huo X, Deng Y, Liu L, Luo G, Jia B, Tong X, Liu L, Ren Z, Miao Z; EPOCH Study and ANGEL-ACT Study Groups. Combined Approach to Eptifibatide and Thrombectomy in Acute Ischemic Stroke Because of Large Vessel Occlusion: A Matched-Control Analysis. Stroke. 2022 May;53(5):1580-1588. doi: 10.1161/STROKEAHA.121.036754. Epub 2022 Feb 2.
PubMed 35105182
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Eptifibatide in Endovascular Treatment of Acute Ischemic Stroke: a Single-arm, Open-label, Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT03844594
- Acronym / sponsor ID
- 2019EPOCH19011912
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic Stroke, Eptifibatide, Endovascular Treatment, Recovery of Dysfunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Ministry of Science and Technology of the People´s Republic of ChinaOther government
- Study start
- 6 Apr 2019 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 18 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a single-arm, open-label, multicenter clinical trial.The primary purpose of this trial is to evaluate the incidence of symptomatic intracranial hemorrhage in patients with acute ischemic stroke within 48 hours after the use of Eptifibatide injection. Patients with acute ischemic stroke treated with intravascular thrombolytic therapy, mechanical thrombolysis, angioplasty and so on were treated with Eptifibatide injection on the first day, followed by the second day, the third day, the discharge day and the 90 days.
Detailed description
The study is a single-arm, open-label, multicenter clinical trial.A total of 220 patients (Age≥18years) with acute ischemic stroke treated with intravascular thrombolysis, mechanical thrombolysis, angioplasty, etc., were treated with Eptifibatide, providing informed consent and medication.The recommended dose of this study was: first, 135ug / kg was injected intravenously or intraductal (within 5 minutes), followed by continuous intravenous infusion of 0.75 ug / kg / min for 24 h. In special cases, it is up to the operator to decide whether to reinject or increase the dosage according to experience. The maximum dose for the first time was 180ug / kg, if necessary, with a 10-minute interval of intravenously or intraductal injection, and a maximum dose of 180ug / kg, intravenously / intraductal injection of no more than 360ug / kg. Continuous intravenous infusion does not exceed 2ug/kg/ Min. Then the second day, the third day, the discharge and 90 days visit. Follow-up information included vital signs and physical examination, observation of symptomatic intracranial hemorrhage, NIHSS scale, and recording of current drug use by AE,SAE.The trial is anticipated to last from January 2019 to December 2019 with 220 subjects recruited form 15 centers in China. All the related investigative organization and individuals will obey the Declaration of Helsinki and Chinese GCP standard. A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study. The trial has been approved by Institutional Review Board (IRB) and Ethics Committee(EC) in Being Tiantan hospital, Capital Medical University.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eptifibatide Drug: Eptifibatide Injection | Experimental | Drug: Eptifibatide Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age≥18 years.
- Acute ischemic stroke.
- Treated with endovascular treatment, including intra-arterial thrombolysis, mechanical thrombectomy, and angioplasty.
- Written informed consent obtained from patient or patient's legally authorized representative.
Key exclusion criteria (11 listed)
- Failed to vascular recanalization (mTICI≤1).
- Diagnosis of intracranial hemorrhagic disease, such as intracranial hemorrhage, subarachnoid hemorrhage and so on.
- Known coagulopathy, Systemic Bleeding Tendency, or baseline platelet count < 100000/mm3.
- History of chronic hepatopathy, liver and kidney dysfunction, elevating ALT (> 3 times normal upper limit), elevating serum creatinine (> 2 times normal upper limit).
- Patients with severe hypertension (systolic blood pressure > 200mmHg or diastolic blood pressure > 110mmHg).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eptifibatide InjectionRecommendation: first, intravenously or intraductal injection of 135ug / kg (completed in 5 minutes), followed by continuous intravenous infusion of 0.75ug / kg / min for 24 hours. | Drug | Eptifibatide Drug: Eptifibatide Injection |
Primary outcome
Symptomatic intracranial hemorrhage
Time frame: Within 48 hours
Incidence of symptomatic Intracranial Hemorrhage within 48 hours after treatment
12 secondary outcomes
Cerebral parenchymal hemorrhage type (PH1) and (PH2)
Time frame: 48 hours
Serious adverse events
Time frame: Within 48 hours
Total death rate
Time frame: Within 48 hours
Adverse events
Time frame: Within 48 hours
Serious adverse events
Time frame: Within 90 days
Total death rate
Time frame: Within 90 days
Adverse events
Time frame: Within 90 days
Vascular recanalization
Time frame: 24 hours
Favorable clinical outcomes
Time frame: 90 days
Neurological recovery
Time frame: 90 days
Recurrent ischemic stroke
Time frame: 90 days
Combined vascular events
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
- Derived from this study: PubMed 35105182Ma G, Sun X, Cheng H, Burgin WS, Luo W, Jia W, Liu Y, He W, Geng X, Zhu L, Chen X, Shi H, Xu H, Zhang L, Wang A, Mo D, Ma N, Gao F, Song L, Huo X, Deng Y, Liu L, Luo G, Jia B, Tong X, Liu L, Ren Z, Miao Z; EPOCH Study and ANGEL-ACT Study Groups. Combined Approach to Eptifibatide and Thrombectomy in Acute Ischemic Stroke Because of Large Vessel Occlusion: A Matched-Control Analysis. Stroke. 2022 May;53(5):1580-1588. doi: 10.1161/STROKEAHA.121.036754. Epub 2022 Feb 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eptifibatide Injection in people with Acute Ischemic Stroke, run by Ministry of Science and Technology of the People´s Republic of China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhongrong Miao, PHD,MD (0086-10-59975211, zhongrongm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptomatic intracranial hemorrhage (time frame: Within 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03844594, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2019.