Bivalirudin in Late PCI for Oatients With STEMI

NCT04185077 | Unknown Phase 4

• 1 other identifier: BJUHFCSOARF201901-20
• Study Type: interventional
• Target: 1,200
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

STEMI - ST Elevation Myocardial Infarction

Keywords

STEMI; late PCI; Bivalirudin; anticoagulation

Outcome Measures

Primary Outcomes (1)

• 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).

  30 days after discharge

Secondary Outcomes (4)

• Rate of major adverse cardiac or cerebral events

  30 days after enrollment

• Rate of any bleeding

  30 days after enrollment

• Rate of stent thrombosis

  30 days after enrollment

• Rate of acquired thrombocytopenia

  30 days after enrollment

Study Arms (2)

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.

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.

Drug: Heparin

Interventions

Bivalirudin DRUG

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

Experimental

Heparin DRUG

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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;

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University: lead

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

bivalirudin; Antithrombins; Heparin

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Serine Proteinase Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Anticoagulants; Hematologic Agents; Therapeutic Uses; Glycosaminoglycans; Polysaccharides; Carbohydrates

Central Study Contacts

Zhaowei Zhu, M.D.

CONTACT

+8615874291260; zhuzhaowei@csu.edu.cn

Shenghua Zhou, M.D.

CONTACT

+8685292012; zhoushenghua@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 29, 2019
• First Posted: December 4, 2019
• Study Start: November 30, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: December 10, 2019

Record last verified: 2019-12