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Bivalirudin in Elderly Patients Undergoing Elective Percutaneous Coronary Intervention.

Primary Purpose

Acute Coronary Syndrome, Percutaneous Coronary Intervention, Aging

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Bivalirudin

Heparin

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Acute Coronary Syndrome, Percutaneous Coronary Intervention, Elderly, Bivalirudin

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥75 years old;
Planned elective PCI for patients with acute coronary syndrome;
Life expectancy ≥ 1 year;
Provide written informed consent.

Exclusion Criteria:

Contraindications to angiography or PCI;
Active bleeding or bleeding constitution, bleeding tendency, including GI or urinary tract hemorrhage (3 months), cerebral hemorrhage (6 months) or cerebral infarction history (3 months), etc;
Other disease may lead to vascular lesions and secondary bleeding factors (such as active gastric ulcer, active ulcerative colitis, intra-cerebral mass, aneurysm, etc.);
Severe renal insufficiency (eGFR < 30 mL/min/ 1.73 m2);
Elevated AST, ALT level higher than three times of the normal upper limit;
Advanced heart failure (NYHA classification grading of cardiac function ≥Ⅲ) Complicated with immune system diseases#
Abnormal hematopoietic system: platelet count < 100 × 109 / L or >700 × 109 / L, white blood cell count < 3×109/L etc;
Suffering from acute infections ,infectious diseases or other serious diseases, such as malignant tumors;
Known intolerance, or contraindication to any antithrombotic medication
Known allergy to the study drugs and instruments (UFH, bivalirudin, aspirin and clopidogrel, stainless steel, contrast agents, etc.), or those allergic constitution.
Non-cardiac co-morbid conditions are present that may result in protocol non-compliance;
Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period;
Patient's inability to fully cooperate with the study protocol

Sites / Locations

The First Affiliated Hospital of Dalian Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bivalirudin

Heparin

Arm Description

Outcomes

Primary Outcome Measures

Major adverse cardiac events

A composite of cardiac death, reinfarction, heart failure,ischemic stroke,frequent post infarction angina, Ventricular tachycardia or fibrillation requiring electrical cardioversion or defibrillation.

Major bleeding

BARC types 3-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding.

Secondary Outcome Measures

Major adverse cardiac events

Stent thrombosis ,TVR ,TLR

Rate of stent thrombosis,unplanned target-vessel revascularization and target lesion revascularisation.

Major adverse cardiac events

Stent thrombosis ,TVR ,TLR

rate of stent thrombosis,unplanned target-vessel revascularization and target lesion revascularisation

Major bleeding

BARC types 3-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding.

Major bleeding

BARC types 3-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding.

Full Information

NCT ID

NCT04046029

First Posted

August 2, 2019

Last Updated

August 2, 2019

Sponsor

The First Affiliated Hospital of Dalian Medical University

Collaborators

Beijing Friendship Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04046029

Brief Title

Bivalirudin in Elderly Patients Undergoing Elective Percutaneous Coronary Intervention.

Official Title

Bivalirudin vs Heparin in Elderly Patients With Acute Coronary Syndrome Undergoing Elective Percutaneous Coronary Intervention

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Unknown status

Study Start Date

July 8, 2019 (Actual)

Primary Completion Date

July 30, 2020 (Anticipated)

Study Completion Date

June 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The First Affiliated Hospital of Dalian Medical University

Collaborators

Beijing Friendship Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The study is an investigator-sponsored, prospective, multicenter, randomized, open-label study designed to compare efficacy and safety between bivalirudin and heparin in elderly patients with acute coronary syndrome undergoing elective percutaneous coronary intervention.

6. Conditions and Keywords

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

Acute Coronary Syndrome, Percutaneous Coronary Intervention, Aging, Anticoagulants and Bleeding Disorders

Keywords

Acute Coronary Syndrome, Percutaneous Coronary Intervention, Elderly, Bivalirudin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Bivalirudin

Arm Type

Experimental

Arm Title

Heparin

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Bivalirudin

Intervention Description

Bivalirudin will be given as a bolus of 0.75 mg/kg followed by infusion of 1.75 mg/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 (0.2 mg/kg/h) for up to 20 hours could be administered at physician discretion. An additional bivalirudin bolus of 0.3 mg/kg was given if the activated clotting time 5 minutes after the initial bolus was less than 225 seconds.

Intervention Type

Drug

Intervention Name(s)

Heparin

Intervention Description

Heparin will be administered at a dose of 70 to 100 units per kilogram in patients not receiving glycoprotein IIb/IIIa inhibitors and at a dose of 50 to 70 units per kilogram in patients receiving glycoprotein IIb/IIIa inhibitors. Subsequent adjustment of the heparin dose on the basis of the activated clotting time will be left to the discretion of the treating physicians.

Primary Outcome Measure Information:

Title

Major adverse cardiac events

Description

Time Frame

7 days

Title

Major bleeding

Description

BARC types 3-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding.

Time Frame

7 days

Secondary Outcome Measure Information:

Title

Major adverse cardiac events

Description

Time Frame

30 days

Title

Stent thrombosis ,TVR ,TLR

Description

Rate of stent thrombosis,unplanned target-vessel revascularization and target lesion revascularisation.

Time Frame

30 days

Title

Major adverse cardiac events

Description

Time Frame

180 days

Title

Stent thrombosis ,TVR ,TLR

Description

rate of stent thrombosis,unplanned target-vessel revascularization and target lesion revascularisation

Time Frame

180 days

Title

Major bleeding

Description

BARC types 3-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding.

Time Frame

30 days

Title

Major bleeding

Description

BARC types 3-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding.

Time Frame

180days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥75 years old; Planned elective PCI for patients with acute coronary syndrome; Life expectancy ≥ 1 year; Provide written informed consent. Exclusion Criteria: Contraindications to angiography or PCI; Active bleeding or bleeding constitution, bleeding tendency, including GI or urinary tract hemorrhage (3 months), cerebral hemorrhage (6 months) or cerebral infarction history (3 months), etc; Other disease may lead to vascular lesions and secondary bleeding factors (such as active gastric ulcer, active ulcerative colitis, intra-cerebral mass, aneurysm, etc.); Severe renal insufficiency (eGFR < 30 mL/min/ 1.73 m2); Elevated AST, ALT level higher than three times of the normal upper limit; Advanced heart failure (NYHA classification grading of cardiac function ≥Ⅲ) Complicated with immune system diseases# Abnormal hematopoietic system: platelet count < 100 × 109 / L or >700 × 109 / L, white blood cell count < 3×109/L etc; Suffering from acute infections ,infectious diseases or other serious diseases, such as malignant tumors; Known intolerance, or contraindication to any antithrombotic medication Known allergy to the study drugs and instruments (UFH, bivalirudin, aspirin and clopidogrel, stainless steel, contrast agents, etc.), or those allergic constitution. Non-cardiac co-morbid conditions are present that may result in protocol non-compliance; Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period; Patient's inability to fully cooperate with the study protocol

Central Contact Person:

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

Shaoke Meng, M.D.

Phone

+86 18098875772

shaokemeng@dmu.edu.cn

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

Rongchong Huang, Ph.D.

Phone

+86 18841182000

rchuang@aliyun.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shaoke Meng, M.D.

Organizational Affiliation

The First Affiliated Hospital of Dalian Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The First Affiliated Hospital of Dalian Medical University

City

Dalian

ZIP/Postal Code

116011

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wei Huang, M.D.

Phone

+86-411-83635963

Ext

3035

dyyykjb@126.com

First Name & Middle Initial & Last Name & Degree

Yinan Wang

Phone

+86-411-83635963

Ext

3015

12. IPD Sharing Statement

Citations:

PubMed Identifier

23636477

Citation

De Caterina R, Husted S, Wallentin L, Andreotti F, Arnesen H, Bachmann F, Baigent C, Huber K, Jespersen J, Kristensen SD, Lip GY, Morais J, Rasmussen LH, Siegbahn A, Verheugt FW, Weitz JI; European Society of Cardiology Working Group on Thrombosis Task Force on Anticoagulants in Heart Disease. Parenteral anticoagulants in heart disease: current status and perspectives (Section II). Position paper of the ESC Working Group on Thrombosis-Task Force on Anticoagulants in Heart Disease. Thromb Haemost. 2013 May;109(5):769-86. doi: 10.1160/TH12-06-0403. Epub 2013 Mar 28.

Results Reference

background

PubMed Identifier

11451763

Citation

Hirsh J, Anand SS, Halperin JL, Fuster V; American Heart Association. AHA Scientific Statement: Guide to anticoagulant therapy: heparin: a statement for healthcare professionals from the American Heart Association. Arterioscler Thromb Vasc Biol. 2001 Jul;21(7):E9-9. doi: 10.1161/hq0701.093520. No abstract available.

Results Reference

background

PubMed Identifier

12087346

Citation

Robson R, White H, Aylward P, Frampton C. Bivalirudin pharmacokinetics and pharmacodynamics: effect of renal function, dose, and gender. Clin Pharmacol Ther. 2002 Jun;71(6):433-9. doi: 10.1067/mcp.2002.124522.

Results Reference

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Bivalirudin in Elderly Patients Undergoing Elective Percutaneous Coronary Intervention.

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