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Bivalirudin in Acute Myocardial Infarction

Primary Purpose

Acute Myocardial Infarction

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Bivalirudin

heparin

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Bivalirudin, Acute myocardial infarction, percutaneous transluminal coronary angioplasty

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Department of Cardiology，General Hospital of Shenyang Military RegionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bivalirudin

Heparin monotherapy

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Net Adverse Clinical Events

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

Secondary Outcome Measures

Major adverse cardiac events (MACE)

A composite of all cause death, reinfarction, target vessel revascularization or stroke

Any bleedings (BARC class)

Including all BARC class (class 3-5)

Full Information

NCT ID

NCT02897037

First Posted

September 7, 2016

Last Updated

November 25, 2016

Sponsor

Shenzhen Salubris Pharmaceuticals Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02897037

Brief Title

Bivalirudin in Acute Myocardial Infarction

Official Title

Bivalirudin vs Heparin During Primary Percutaneous Coronary Intervention in Acute Myocardial Infarction: A Randomised Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Unknown status

Study Start Date

November 2016 (undefined)

Primary Completion Date

June 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shenzhen Salubris Pharmaceuticals Co., Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

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. The purpose of the study is to evaluate the efficacy and safety of bivalirudin in AMI patients with DES.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myocardial Infarction

Keywords

Bivalirudin, Acute myocardial infarction, percutaneous transluminal coronary angioplasty

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

380 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Bivalirudin

Arm Type

Experimental

Arm Description

Arm Title

Heparin monotherapy

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Bivalirudin

Other Intervention Name(s)

Taijianing

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

heparin

Other Intervention Name(s)

Gansu

Intervention Description

heparin monotherapy

Primary Outcome Measure Information:

Title

Net Adverse Clinical Events

Description

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

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Major adverse cardiac events (MACE)

Description

A composite of all cause death, reinfarction, target vessel revascularization or stroke

Time Frame

30 days

Title

Any bleedings (BARC class)

Description

Including all BARC class (class 3-5)

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jiangjing Long, Dr.

Phone

86-10-58696282

Ext

840

longjianjing@salubris.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Yan Hou, Dr.

Phone

86-10-58696282

Ext

821

houyan@salubris.cn

Facility Information:

Facility Name

Department of Cardiology，General Hospital of Shenyang Military Region

City

Shanyang

State/Province

Liaoning

ZIP/Postal Code

110016

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhenyang Liang, Dr.

Phone

86-13332457575

doctorliangzi@sina.com

First Name & Middle Initial & Last Name & Degree

Yi Li

doctorliyi@126.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Bivalirudin in Acute Myocardial Infarction

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