STEMI - ST Elevation Myocardial InfarctionPhase 4BETTERNCT04185077
Bivalirudin in Late PCI for Oatients With STEMI
A Phase 4 study testing Bivalirudin and Heparin in people with STEMI - ST Elevation Myocardial Infarction, run by Second Xiangya Hospital of Central South University.
Trial summary
Bivalirudin is recomended by guidelines during primary PCI procedure for patients with STEMI. However, there is a large number of STEMI patients who missed the primary PCI. So the investigators aim to study the efficiency and safety of bivalirudin as the anticoagulation therapy during late PCI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- STEMI - ST Elevation Myocardial Infarction
- What is being tested?
- Bivalirudin and Heparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2019to 31 Dec 2020
- Phase
- Phase 4
- 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
- Patients aged over 18 years.
- Patients with ST-segment elevation MI (STEMI) undergoing late PCI 24 hours to 2 weeks after symptom onset. STEMI was defined as ST-segment elevation ≥0.1 mV in ≥2 contiguous leads or documented newly developed left bundle branch block.
- Patients with develop Q-waves at presentation and with clear culprit vessel confirmed by angiography or other clinical evidences.
- No any other anticoagulation therapy 12 hours before late PCI.
Who cannot join
- STEMI patients undergoing primary PCI in 24 hours after symptom attack; patient unwilling or unable to provide written informed consent. thrombolytic therapy administered before randomization; any condition making PCI unsuitable or that might interfere with study adherence;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Efficiency and Safety of Bivalirudin in latE percuTaneous Coronary inTervention for Patients With ST-Elevation Myocardial InfaRction (BETTER Trial)
Bivalirudin is recomended by guidelines during primary PCI procedure for patients with STEMI. However, there is a large number of STEMI patients who missed the primary PCI. So the investigators aim to study the efficiency and safety of bivalirudin as the anticoagulation therapy during late PCI.
Read the detailed description
Antithrombotic therapy is essential to prevent adverse ischemic events, especially stent thrombosis and reinfarction during and after primary percutaneous coronary intervention (PCI) in patients with acute myocardial infarction (AMI). Bivalirudin is emerging as an alternative for heparin during PCI procedure1.
Bivalirudin (BIV) a synthetic, bivalent, 20-amino acid direct thrombin inhibitor, was found to have the advantages of inhibiting fibrin-bound thrombin, a predictable effect of anticoagulation, and a short half-life of approximately 30 minutes in humans with normal renal function. BIV has been introduced in percutaneous coronary interventions (PCIs) especially for patients with ACS. Compared with heparin, series clinical trials indicated that BIV was not inferior to UFH as a procedural anticoagulant and there was no increased bleeding.
In the real world, there are as many as 47.1% patients with STEMI can not get early reperfusion therapy. Huge number of patients missed the best time window for PCI. For these patients, the usual PCI procedure are usually performed 1-2 weeks after attack, which is called late PCI.
For patients with STEMI, Bivalirudin is recomended by guidelines in ESC during PCI procedure. However, the evidences (ACUITY，HORIZONS-AMI，EUROMAX, EAT-PPCI，BRIGHT, VALIDATE-SWEDEHEART) supporting the guideline nearly all comes from primary PCI for STEMI, which means there has no clinical trials focus on late PCI for patients with STEMI yet.
Clinically, late PCI, defined as the time to open an infarct-related artery (IRA) from symptoms onset > 7 days (when the myocardial condition is considered stable), is practiced commonly for these late presenters. Whether late PCI is adequately beneficial is controversial. Currently, heparin is applied during late PCI as the anticoagulation therapy, it is still unknown of the efficiency and safety for bivalirudin as the anticoagulation therapy during late PCI.
So in this RCTs, the investigators aim to study the efficiency and safety of bivalirudin as the anticoagulation therapy during late PCI.
- Being tested
- Bivalirudin, Heparin
- Keywords
- STEMI, late PCI, Bivalirudin, anticoagulation
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BivalirudinDrug
Also called Direct thrombin inhibitor
Bivalirudin (Salubris Pharmaceuticals Co) was given as a bolus of 0.75mg/kg followed by infusion of 1.75mg/kg/h during the PCI procedure and for at least 30 minutes but no more than 4 hours afterwards. Following this mandatory infusion, a reduced-dose infusion (0.2mg/kg/h) for up to 20 hours could be administered at physician discretion. An additional bivalirudin bolus of0.3mg/kgwasgivenif the activatedclotting time 5minutes after the initial bolus (measuredwith the Hemotec assay) was less than 225 seconds.
HeparinDrug
Also called unfractionated heparin
a bolus dose of 100 U/kg was administered according to current guidelines.Additional heparinwasadministered if the post-bolus activated clotting time was less than 225 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Bivalirudin (Salubris Pharmaceuticals Co) was given as a bolus of 0.75mg/kg followed by infusion of 1.75mg/kg/h during the PCI procedure and for at least 30 minutes but no more than 4 hours afterwards. Following this mandatory infusion, a reduced-dose infusion (0.2mg/kg/h) for up to 20 hours could be administered at physician discretion. An additional bivalirudin bolus of0.3mg/kgwasgivenif the activatedclotting time 5minutes after the initial bolus (measuredwith the Hemotec assay) was less than 225 seconds. Receives: Drug: Bivalirudin |
| Control | Active comparator | a bolus dose of 100 U/kg Heparin was administered according to current guidelines.Additional heparinwasadministered if the post-bolus activated clotting time was less than 225 seconds. Receives: Drug: Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of net adverse clinical events
a composite of major adverse cardiac or cerebral events (all-cause death, reinfarction, ischemia-driven target vessel revascularization, or stroke) or any bleeding as defined by the Bleeding Academic Research Consortium(BARC) definition (grades 1-5).
Measured: 30 days after discharge
Secondary outcomes (4)
Rate of major adverse cardiac or cerebral events
all-cause death, reinfarction, ischemia-driven target vessel revascularization, or stroke
Measured: 30 days after enrollment
Rate of any bleeding
Bleeding was considered medically actionable if BARC types 2 through 5 and was considered major if BARC types 3 through 5 occurred.
Measured: 30 days after enrollment
Rate of stent thrombosis
according to the Academic Research Consortium criteria
Measured: 30 days after enrollment
Rate of acquired thrombocytopenia
defined as a platelet count decrease ofmore than50%or more than 150 × 109/L frombaseline
Measured: 30 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start30 Nov 2019 (estimated)
- Primary completion31 Dec 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.
- Other trials for STEMI - ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Second Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shenghua Zhou, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185077
- Sponsor's protocol ID
- BJUHFCSOARF201901-20
- Acronym
- BETTER
- Status last verified
- Dec 2019
- First submitted
- 29 Nov 2019
- Last updated
- 10 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficiency and Safety of Bivalirudin in latE percuTaneous Coronary inTervention for Patients With ST-Elevation Myocardial InfaRction (BETTER Trial)
- ClinicalTrials.gov ID
- NCT04185077
- Acronym / sponsor ID
- BETTER / BJUHFCSOARF201901-20
- Keywords
- STEMI, late PCI, Bivalirudin, anticoagulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 30 Nov 2019 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 4 Dec 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.
Bivalirudin is recomended by guidelines during primary PCI procedure for patients with STEMI. However, there is a large number of STEMI patients who missed the primary PCI. So the investigators aim to study the efficiency and safety of bivalirudin as the anticoagulation therapy during late PCI.
Detailed description
Antithrombotic therapy is essential to prevent adverse ischemic events, especially stent thrombosis and reinfarction during and after primary percutaneous coronary intervention (PCI) in patients with acute myocardial infarction (AMI). Bivalirudin is emerging as an alternative for heparin during PCI procedure1.
Bivalirudin (BIV) a synthetic, bivalent, 20-amino acid direct thrombin inhibitor, was found to have the advantages of inhibiting fibrin-bound thrombin, a predictable effect of anticoagulation, and a short half-life of approximately 30 minutes in humans with normal renal function. BIV has been introduced in percutaneous coronary interventions (PCIs) especially for patients with ACS. Compared with heparin, series clinical trials indicated that BIV was not inferior to UFH as a procedural anticoagulant and there was no increased bleeding.
In the real world, there are as many as 47.1% patients with STEMI can not get early reperfusion therapy. Huge number of patients missed the best time window for PCI. For these patients, the usual PCI procedure are usually performed 1-2 weeks after attack, which is called late PCI.
For patients with STEMI, Bivalirudin is recomended by guidelines in ESC during PCI procedure. However, the evidences (ACUITY，HORIZONS-AMI，EUROMAX, EAT-PPCI，BRIGHT, VALIDATE-SWEDEHEART) supporting the guideline nearly all comes from primary PCI for STEMI, which means there has no clinical trials focus on late PCI for patients with STEMI yet.
Clinically, late PCI, defined as the time to open an infarct-related artery (IRA) from symptoms onset > 7 days (when the myocardial condition is considered stable), is practiced commonly for these late presenters. Whether late PCI is adequately beneficial is controversial. Currently, heparin is applied during late PCI as the anticoagulation therapy, it is still unknown of the efficiency and safety for bivalirudin as the anticoagulation therapy during late PCI.
So in this RCTs, the investigators aim to study the efficiency and safety of bivalirudin as the anticoagulation therapy during late PCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: BivalirudinBivalirudin (Salubris Pharmaceuticals Co) was given as a bolus of 0.75mg/kg followed by infusion of 1.75mg/kg/h during the PCI procedure and for at least 30 minutes but no more than 4 hours afterwards. Following this mandatory infusion, a reduced-dose infusion (0.2mg/kg/h) for up to 20 hours could be administered at physician discretion. An additional bivalirudin bolus of0.3mg/kgwasgivenif the activatedclotting time 5minutes after the initial bolus (measuredwith the Hemotec assay) was less than 225 seconds. |
| Control | Active comparator | Drug: Heparina bolus dose of 100 U/kg Heparin was administered according to current guidelines.Additional heparinwasadministered if the post-bolus activated clotting time was less than 225 seconds. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged over 18 years.
- Patients with ST-segment elevation MI (STEMI) undergoing late PCI 24 hours to 2 weeks after symptom onset. STEMI was defined as ST-segment elevation ≥0.1 mV in ≥2 contiguous leads or documented newly developed left bundle branch block.
- Patients with develop Q-waves at presentation and with clear culprit vessel confirmed by angiography or other clinical evidences.
- No any other anticoagulation therapy 12 hours before late PCI.
Key exclusion criteria (1 listed)
- STEMI patients undergoing primary PCI in 24 hours after symptom attack; patient unwilling or unable to provide written informed consent. thrombolytic therapy administered before randomization; any condition making PCI unsuitable or that might interfere with study adherence;
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 |
|---|---|---|
| BivalirudinAlso: Direct thrombin inhibitorBivalirudin (Salubris Pharmaceuticals Co) was given as a bolus of 0.75mg/kg followed by infusion of 1.75mg/kg/h during the PCI procedure and for at least 30 minutes but no more than 4 hours afterwards. Following this mandatory infusion, a reduced-dose infusion (0.2mg/kg/h) for up to 20 hours could be administered at physician discretion. An additional bivalirudin bolus of0.3mg/kgwasgivenif the activatedclotting time 5minutes after the initial bolus (measuredwith the Hemotec assay) was less than 225 seconds. | Drug | Experimental |
| HeparinAlso: unfractionated heparina bolus dose of 100 U/kg was administered according to current guidelines.Additional heparinwasadministered if the post-bolus activated clotting time was less than 225 seconds. | Drug | Control |
Primary outcome
Rate of net adverse clinical events
Time frame: 30 days after discharge
a composite of major adverse cardiac or cerebral events (all-cause death, reinfarction, ischemia-driven target vessel revascularization, or stroke) or any bleeding as defined by the Bleeding Academic Research Consortium(BARC) definition (grades 1-5).
4 secondary outcomes
Rate of major adverse cardiac or cerebral events
Time frame: 30 days after enrollment
Rate of any bleeding
Time frame: 30 days after enrollment
Rate of stent thrombosis
Time frame: 30 days after enrollment
Rate of acquired thrombocytopenia
Time frame: 30 days after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bivalirudin and Heparin in people with STEMI - ST Elevation Myocardial Infarction, run by Second Xiangya Hospital of Central South University.
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 1 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 10 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Zhaowei Zhu, M.D. (+8615874291260, zhuzhaowei@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of net adverse clinical events (time frame: 30 days after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2019.