NCT04046029

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.

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
240

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 8, 2019

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

August 2, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

August 6, 2019

Status Verified

July 1, 2019

Enrollment Period

1.1 years

First QC Date

August 2, 2019

Last Update Submit

August 2, 2019

Conditions

Acute Coronary SyndromePercutaneous Coronary InterventionAgingAnticoagulants and Bleeding Disorders

Keywords

Acute Coronary SyndromePercutaneous Coronary InterventionElderlyBivalirudin

Outcome Measures

Primary Outcomes (2)

  • 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.

    7 days

  • Major bleeding

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

    7 days

Secondary Outcomes (6)

  • Major adverse cardiac events

    30 days

  • Stent thrombosis ,TVR ,TLR

    30 days

  • Major adverse cardiac events

    180 days

  • Stent thrombosis ,TVR ,TLR

    180 days

  • Major bleeding

    30 days

  • +1 more secondary outcomes

Study Arms (2)

Bivalirudin

EXPERIMENTAL
Drug: Bivalirudin

Heparin

ACTIVE COMPARATOR
Drug: Heparin

Interventions

BivalirudinDRUG

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.

Bivalirudin
HeparinDRUG

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.

Heparin

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Dalian Medical University

Dalian, 116011, China

RECRUITING

Related Publications (3)

  • 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.

    PMID: 23636477BACKGROUND

  • 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.

    PMID: 11451763BACKGROUND

  • 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.

    PMID: 12087346BACKGROUND

MeSH Terms

Conditions

Acute Coronary SyndromeHemostatic Disorders

Interventions

bivalirudinHeparin

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Shaoke Meng, M.D.

    The First Affiliated Hospital of Dalian Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shaoke Meng, M.D.

CONTACT

+86 18098875772shaokemeng@dmu.edu.cn

Rongchong Huang, Ph.D.

CONTACT

+86 18841182000rchuang@aliyun.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2019

First Posted

August 6, 2019

Study Start

July 8, 2019

Primary Completion

July 30, 2020

Study Completion

June 30, 2021

Last Updated

August 6, 2019

Record last verified: 2019-07

Locations

CN(1)