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Status unknownNCT04046029Updated Aug 6, 2019

Bivalirudin in Elderly Patients Undergoing Elective Percutaneous Coronary Intervention.

A Phase 4 interventional study of Bivalirudin and Heparin in Acute Coronary Syndrome, Percutaneous Coronary Intervention and Aging, sponsored by The First Affiliated Hospital of Dalian Medical University. Status unknown at 1 site in China. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2019-08-06.

Sponsored by The First Affiliated Hospital of Dalian Medical University · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
75 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • Acute Coronary Syndrome
  • Percutaneous Coronary Intervention
  • Elderly
  • Bivalirudin
03

In context

Acute Coronary Syndrome

1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.

This study's planned enrollment of 240 is above the median of 200 across 869 interventional studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

The First Affiliated Hospital of Dalian Medical University is the lead sponsor of 41 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
75 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
240 participants (estimated)

Study arms

  • Experimental
    Bivalirudin

    Drug: Bivalirudin

  • Active comparator
    Heparin

    Drug: Heparin

Interventions

  • DrugBivalirudin

    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.

  • DrugHeparin

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 7 days

  2. Major bleeding

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

    Time frame: 7 days

Secondary outcomes

  1. 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.

    Time frame: 30 days

  2. Stent thrombosis ,TVR ,TLR

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

    Time frame: 30 days

  3. 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.

    Time frame: 180 days

  4. Stent thrombosis ,TVR ,TLR

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

    Time frame: 180 days

  5. Major bleeding

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

    Time frame: 30 days

  6. Major bleeding

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

    Time frame: 180days

07

Study locations

1 of 1 sites recruiting
  • The First Affiliated Hospital of Dalian Medical University
    Dalian, 116011, China
    • Wei Huang, M.D. · Contact · dyyykjb@126.com · +86-411-83635963
    • Yinan Wang · Contact · +86-411-83635963
    Recruiting
08

References and documents

Publications

  • 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. PubMed 23636477 ↗
  • 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. PubMed 11451763 ↗
  • 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. PubMed 12087346 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04046029
Lead sponsor
The First Affiliated Hospital of Dalian Medical University
Collaborators
Beijing Friendship Hospital
Responsible party
Sponsor
First posted
Aug 6, 2019
Start date
Jul 8, 2019
Primary completion
Jul 30, 2020 (estimated)
Completion
Jun 30, 2021 (estimated)
Last update
Aug 6, 2019

Study contacts

Shaoke Meng, M.D.
Contact
shaokemeng@dmu.edu.cn
+86 18098875772
Rongchong Huang, Ph.D.
Contact
rchuang@aliyun.com
+86 18841182000
Shaoke Meng, M.D.
principal investigator · The First Affiliated Hospital of Dalian Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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