NCT02897037

Brief Summary

The purpose of the study is to evaluate the efficacy and safety of bivalirudin in AMI patients with DES. This is a prospective, randomized, single-blind, active drug controlled multicenter clinical research and the study would enrolled a total of 380 AMI patients undergoing percutaneous coronary intervention (PCI) to one of two antithrombotic regimens: bivalirudin alone, or unfractionated heparin alone. All enrolled patients would be followed-up to 30 days.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
380

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

November 28, 2016

Status Verified

November 1, 2016

Enrollment Period

7 months

First QC Date

September 7, 2016

Last Update Submit

November 25, 2016

Conditions

Acute Myocardial Infarction

Keywords

BivalirudinAcute myocardial infarctionpercutaneous transluminal coronary angioplasty

Outcome Measures

Primary Outcomes (1)

  • Net Adverse Clinical Events

    A composite of all cause death, reinfarction, urgent target vessel revascularization, stroke and any bleedings

    30 days

Secondary Outcomes (2)

  • Major adverse cardiac events (MACE)

    30 days

  • Any bleedings (BARC class)

    30 days

Study Arms (2)

Bivalirudin

EXPERIMENTAL

Bivalirudin will be started in the cath lab, 0.75 mg/kg intravenous bolus followed by 1.75 mg/kg per h infusion; if ACT\<225s 5min after bolus, an additional dose of 0.3mg/kg bolus should be given. After procedure, a prolonged infusion (1.75mg/kg per h) will be given for at least 30 min (totally no more than 4 h) followed by a reduced dose infusion (0.2mg/kg per h) up to 20 h.

Drug: Bivalirudin

Heparin monotherapy

ACTIVE COMPARATOR

100 IU/kg intravenous bolus. If ACT \<225s 5 min after bolus injection, additional dose of heparin (20U/kg) will be given.

Drug: heparin

Interventions

BivalirudinDRUG

Patients would be given anticoagulant therapy with bivalirudin in acute myocardial infarction during emergency PCI operation.

Also known as: Taijianing
Bivalirudin
heparinDRUG

heparin monotherapy

Also known as: Gansu
Heparin monotherapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 to 80 years old
  • Planned emergency PCI for acute myocardial infarction (STEMI) Symptom onset within 12h for STEMI (or within 12-24 hrs for patients have unrelieved chest pain, continuous ST elevation or new developed LBBB)
  • Provide written informed consent.

You may not qualify if:

  • Age \<18 or \>80 years.
  • Any anticoagulant drugs were regularly used within 3 months.
  • Any anticoagulant agents were used 48 h before randomization.
  • Active bleeding or bleeding constitution, bleeding tendency, including the recent retina or vitreous hemorrhage (1 months), GI or urinary tract hemorrhage (3 months), cerebral hemorrhage (6 months) or cerebral infarction history (3 months), etc.
  • Hemoglobin \< 90 g/L or platelet count \< 100 \* 109 / L.
  • Untreated or uncontrolled hypertension \> 180/110 mmHg.
  • Elevated ALT level higher than three times of the normal upper limit;severe renal insufficiency (eGFR \< 30 mL/min / 1.73 m2).
  • Heparin induced thrombocytopenia.
  • Suspicious aortic dissection, pericarditis and subacute bacterial endocarditis.
  • Known allergy to the study drugs and instruments (UFH, bivalirudin, aspirin and clopidogrel, stainless steel, contrast agents, etc.), or those allergic constitution.
  • Pregnancy , lactation or plan to be pregnant.
  • Known serious progressive diseases such as malignant tumor or prognosis of the patients with severe failure;the survival time \< 6 months.
  • Unsuitable for PCI.
  • Attended any clinical trial 1 month before randomised.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology，General Hospital of Shenyang Military Region

Shanyang, Liaoning, 110016, China

RECRUITING

MeSH Terms

Interventions

bivalirudinHeparin

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Central Study Contacts

Jiangjing Long, Dr.

CONTACT

86-10-58696282longjianjing@salubris.cn

Yan Hou, Dr.

CONTACT

86-10-58696282houyan@salubris.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2016

First Posted

September 12, 2016

Study Start

November 1, 2016

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

November 28, 2016

Record last verified: 2016-11

Locations

CN(1)