A Phase 4 interventional study of Bivalirudin and Heparin in STEMI - ST Elevation Myocardial Infarction, sponsored by Second Xiangya Hospital of Central South University. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-10.
Sponsored by Second Xiangya Hospital of Central South University · Phase 4, Interventional, and Treatment
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.
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.
688 studies on the registry are indexed under ST Elevation Myocardial Infarction; 184 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 194 across 439 interventional studies indexed under ST Elevation Myocardial Infarction.
Browse ST Elevation Myocardial Infarction studies →Second Xiangya Hospital of Central South University is the lead sponsor of 87 studies on the registry; 50 are open to participants now.
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Exclusion Criteria:
- 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;
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.
Drug: Bivalirudin
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.
Drug: Heparin
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.
Also known as: Direct thrombin inhibitor
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.
Also known as: unfractionated heparin
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).
Time frame: 30 days after discharge
Rate of major adverse cardiac or cerebral events
all-cause death, reinfarction, ischemia-driven target vessel revascularization, or stroke
Time frame: 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.
Time frame: 30 days after enrollment
Rate of stent thrombosis
according to the Academic Research Consortium criteria
Time frame: 30 days after enrollment
Rate of acquired thrombocytopenia
defined as a platelet count decrease ofmore than50%or more than 150 × 109/L frombaseline
Time frame: 30 days after enrollment
No study locations are listed for this record.
Start is estimated for Nov 2019; primary completion for Dec 2020, 13 months later.
Of 36 non-industry phase 4 interventional studies under ST Elevation Myocardial Infarction, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 74. This study's planned 13 months is below that.
Counting every sponsor, half of 39 studies reached it within 32 months; a quarter within 21 and three quarters within 74.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bivalirudin
ST Elevation Myocardial Infarction →
Second Xiangya Hospital of Central South University