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Optimizing the Anticoagulation Regimen of Enoxaparin During Percutaneous Coronary Intervention (OPTIENOX-PCI) (OPTIENOX-PCI)

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ClinicalTrials.gov Identifier: NCT03145675
Recruitment Status : Recruiting
First Posted : May 9, 2017
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
LiuZhenyu, Peking Union Medical College Hospital

Brief Summary:
The OPTIENOX-PCI is a randomized study, which is designed to assess the anticoagulation profile of different dose regimens of enoxaparin, i.e., 0.5 mg/kg, 0.75 mg/kg, and 0.5 mg/kg with additional 0.25 mg/kg, in about 120 patients who plan to undergo elective trans-radial coronary angiography with or without subsequent PCI.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Percutaneous Coronary Intervention Drug: Enoxaparin (Staged-dose PCI Group) Drug: Enoxaparin (Single-dose PCI Group) Drug: Enoxaparin (High-dose Group) Drug: Enoxaparin (Standard-dose Group) Phase 4

Detailed Description:

After eligible patients are randomized into Planned Staged-dose Group and Planned Single-dose Group, first-dose anticoagulation will be administered immediately. All patients in the Planned Staged-dose Group will receive enoxaparin 0.5 mg/kg at the beginning of coronary angiography and only those with definite indication for subsequent PCI will be given additional enoxaparin 0.25 mg/kg at the beginning of PCI; while, all patients in the Planned Single-dose Group will receive enoxaparin 0.75 mg/kg at the beginning of coronary angiography irrespective of their indication for subsequent PCI. Blood samples for the measurement of Anti-Xa activity will be obtained at 0 min (immediately before first-dose administration), 10 min, 90 min, 180 min after first-dose administration in all patients. Additional blood samples for Anti-Xa assessment will be collected only in patients undergoing subsequent PCI immediately before and at 10 min after the beginning of PCI, as well as at the end of PCI. The primary objective of the present study is to obtain the values of Anti-Xa activity at the above time points in each group of patients. In patients who undergo subsequent PCI, the proportion of patients with therapeutic anticoagulation (Anti-Xa 0.5-1.8 IU/ml) at 10 min after the beginning of PCI and at 90 min after first-dose administration will be compared respectively between the two groups (Staged-dose PCI Group [0.5+0.25 mg/kg] versus Single-dose PCI Group [0.75 mg/kg]). In patients who do not undergo subsequent PCI, the proportion of patients with therapeutic anticoagulation at 10 min and 90 min after first-dose administration will be compared respectively between the two groups (High-dose Group [0.75 mg/kg] versus Standard-dose Group [0.5 mg/kg]).

In conclusion, the OPTIENOX-PCI study will 1) obtain the Anti-Xa activity of enoxaparin at each time point of sampling; 2) assess the anticoagulation profile of high- versus standard-dose enoxaparin (0.75 mg/kg vs. 0.5 mg/kg), as well as that of staged- versus single-administration of high-dose enoxaparin (0.5+0.25 mg/kg vs. 0.75 mg/kg). The result of the present study will provide pharmacodynamical data for the design of future outcome studies.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Eligible patients are randomized into Planned Staged-dose Group and Planned Single-dose Group.

All patients in the Planned Staged-dose Group will receive enoxaparin 0.5 mg/kg at the beginning of coronary angiography. Those with definite indication for subsequent PCI will be given additional enoxaparin 0.25 mg/kg at the beginning of PCI (Staged-dose PCI Group [0.5+0.25 mg/kg]); while, those have no indication for subsequent PCI will not receive additional anticoagulation (Standard-dose Group [0.5 mg/kg]).

All patients in the Planned Single-dose Group will receive enoxaparin 0.75 mg/kg at the beginning of coronary angiography no matter they will undergo subsequent PCI (Single-dose PCI Group [0.75 mg/kg]) or not (High-dose Group [0.75 mg/kg]).

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimizing the Anticoagulation Regimen of Enoxaparin During Percutaneous Coronary Intervention
Actual Study Start Date : May 12, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Arm Intervention/treatment
Experimental: Enoxaparin (Staged-dose PCI Group)
Enoxaparin 0.5 mg/kg at the beginning of coronary angiography (i.e., insertion of angiographic catheter) and additional enoxaparin 0.25 mg/kg at the beginning of PCI (i.e., insertion of guiding catheter).
Drug: Enoxaparin (Staged-dose PCI Group)
Enoxaparin 0.5+0.25 mg/kg administered intravenously.
Other Name: Clexane

Active Comparator: Enoxaparin (Single-dose PCI Group)
Enoxaparin 0.75 mg/kg at the beginning of coronary angiography (i.e., insertion of angiographic catheter) and NO additional enoxaparin at the beginning of PCI (i.e., insertion of guiding catheter).
Drug: Enoxaparin (Single-dose PCI Group)
Enoxaparin 0.75 mg/kg administered intravenously.
Other Name: Clexane

Experimental: Enoxaparin (High-dose Group)
Enoxaparin 0.75 mg/kg at the beginning of coronary angiography (i.e., insertion of angiographic catheter).
Drug: Enoxaparin (High-dose Group)
Enoxaparin 0.75 mg/kg administered intravenously.
Other Name: Clexane

Active Comparator: Enoxaparin (Standard-dose Group)
Enoxaparin 0.5 mg/kg at the beginning of coronary angiography (i.e., insertion of angiographic catheter).
Drug: Enoxaparin (Standard-dose Group)
Enoxaparin 0.5 mg/kg administered intravenously.
Other Name: Clexane




Primary Outcome Measures :
  1. Therapeutic anticoagulation (in patients NOT undergoing PCI, i.e., High-dose Group versus Standard-dose Group). [ Time Frame: At 10 min after first-dose administration in patients NOT undergoing PCI. ]
    The proportion of patients with Anti-Xa 0.5-1.8 IU/ml (0.75 mg/kg versus 0.5 mg/kg).

  2. Therapeutic anticoagulation (in patients undergoing PCI, i.e., Staged-dose PCI Group versus Single-dose PCI Group). [ Time Frame: At 10 min after the beginning of PCI (i.e., insertion of guiding catheter) in patients undergoing PCI. ]
    The proportion of patients with Anti-Xa 0.5-1.8 IU/ml (0.5+0.25 mg/kg versus 0.75 mg/kg).


Secondary Outcome Measures :
  1. Therapeutic anticoagulation. [ Time Frame: At 90 min after first-dose administration. ]
    The proportion of patients with Anti-Xa 0.5-1.8 IU/ml.


Other Outcome Measures:
  1. Major adverse cardiac events (MACE). [ Time Frame: Up to 24 hours. ]
    The proportion of patients with the composite of death, or myocardial infarction, or urgent coronary revascularization, or definite or probable stent thrombosis.

  2. Thrombolysis in myocardial infarction (TIMI) major or minor bleeding. [ Time Frame: Up to 24 hours. ]
    The proportion of patients with the composite of TIMI major or minor bleeding.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of written informed consent.
  2. Aged 18 years or older, male or female.
  3. Documented stable coronary artery disease (SCAD) or non-ST-segment elevation acute coronary syndromes (NSTE-ACS).
  4. Plan to undergo elective trans-radial coronary angiography with or without subsequent PCI.
  5. No fibrinolytic, or anticoagulant, or parenteral antiplatelet therapy within 7 days of screening.
  6. Negative cardiac troponin test within 7 days of screening.
  7. Trans-radial approach successfully established.
  8. Females who are either post-menopausal > 1 year or surgically sterile.

Exclusion Criteria:

  1. Recent (within 30 days of screening) acute myocardial infarction, including ST-segment elevation myocardial infarction or non-ST-segment elevation myocardial infarction.
  2. The aim of the index coronary angiography is to undergo primary PCI or early PCI for acute coronary syndromes.
  3. Any indications other than coronary artery disease (e.g., atrial fibrillation, prosthetic heart valve, venous thromboembolism, ventricular thrombosis, et al) for fibrinolytic or anticoagulant treatment during study period.
  4. Planned use of any fibrinolytic or antithrombotic agents, with the exception of enoxaparin, aspirin, clopidogrel, and ticagrelor during study period.
  5. Planned coronary artery bypass graft (CABG) during study period.
  6. Increased bleeding risk, including

    • any history of intracranial, intraocular, retroperitoneal, or spinal bleeding;
    • recent (within 30 days of screening) gastrointestinal (GI) bleeding;
    • recent (within 30 days of screening) major trauma or major surgery;
    • planned surgery or other invasive procedure during study period;
    • sustained uncontrolled hypertension (systolic blood pressure [SBP] > 180 mmHg or diastolic blood pressure [DBP] > 100 mmHg) within 7 days of screening;
    • history of hemorrhagic disorders, e.g., haemophilia, von Willebrand's disease;
    • inability to discontinue non-steroidal anti-inflammatory drugs (NSAIDs) during study period;
    • platelet count less than 100,000/mm3 or hemoglobin < 10 g/dL within 7 days of screening.
  7. Contraindications for enoxaparin, e.g., hypersensitivity, active bleeding, bleeding diathesis, coagulation disorders, acute infectious endocarditis, thrombocytopenia (including heparin-induced thrombocytopenia), cerebral hemorrhage, severe liver of kidney diseases, severe hypertension, stroke, retinopathy, et al.
  8. History of intolerance to enoxaparin.
  9. Patient requires dialysis or has a creatinine clearance < 30 mL/min as calculated by the Cockcroft-Gault equation: Clcr = (140 - Age) × WT / (72 × Scr) (× 0.85 for females), where WT is weight in kg, Scr is serum creatinine in mg/dL measured within 7 days of screening.
  10. Any acute or chronic unstable conditions in the past 30 days which, in the opinion of the investigator, may either put the patient at risk or influence the result of the study, e.g., active cancer, et al.
  11. Any condition that may increase the risk of non-compliance to study protocol or follow-up, e.g., history of drug addiction or alcohol abuse, et al.
  12. Patients who has previously been randomized in this study.
  13. Participation in another investigational drug or device study within 30 days of screening.
  14. Involvement in the planning and conduct of the study (applies to investigators, contract research organization staff, and study site staff).
  15. Known pregnancy, breast-feeding, or intend to become pregnant during the study period.
  16. Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03145675


Contacts
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Contact: Zhenyu Liu, M.D. +861069155068 pumch_lzy@163.com
Contact: Lihong Xu, B.N. +861069155068 xulihong1990@163.com

Locations
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China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Zhenyu Liu, M.D.    +861069155068    pumch_lzy@163.com   
Contact: Lihong Xu, B.N.    +861069155068    xulihong1990@163.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Principal Investigator: Zhenyu Liu, M.D. Department of Cardiology, Peking Union Medical College Hospital

Publications of Results:
Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Writing Group on the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction, Thygesen K, Alpert JS, White HD, Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA, Chaitman BA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasché P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S; ESC Committee for Practice Guidelines (CPG). Third universal definition of myocardial infarction. Eur Heart J. 2012 Oct;33(20):2551-67. doi: 10.1093/eurheartj/ehs184. Epub 2012 Aug 24.

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Responsible Party: LiuZhenyu, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03145675     History of Changes
Other Study ID Numbers: PUMCH-2016-2.24
JS-1286 ( Other Identifier: Ethics Committee of Peking Union Medical College Hospital )
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by LiuZhenyu, Peking Union Medical College Hospital:
Anticoagulation
Enoxaparin
Dose
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Enoxaparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action