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

NCT03145675 | Completed Phase 4

• 2 other identifiers: PUMCH-2016-2.24JS-1286
• Study Type: interventional
• Target: 378
• Locations: 1 country
• Sites: 1

Brief Summary

The OPTIENOX-PCI is a single-center, prospective, randomized, open-label, controlled study, which is designed to assess the anticoagulation profile of: 1) High-dose (0.75 mg/kg) vs. Standard-dose (0.5 mg/kg) enoxaparin; 2) Staged-dose (0.5+0.25 mg/kg) vs. Single-dose (0.75 mg/kg) enoxaparin in about 376 patients who plan to undergo elective trans-radial coronary angiography (CAG) with or without subsequent percutaneous coronary intervention (PCI).

Conditions

Coronary Artery Disease; Percutaneous Coronary Intervention

Keywords

Anticoagulation; Enoxaparin; Dose

Outcome Measures

Primary Outcomes (2)

• Anti-Xa level (CAG-90 min) in the High-dose vs. the Standard-dose group.

  The anti-Xa level (CAG-90 min) in the High-dose vs. the Standard-dose group.

  At 90 min after the first dose enoxaparin is given.

• Anti-Xa level (CAG-90 min) in the Staged-dose PCI vs. the Single-dose PCI group.

  The anti-Xa level (CAG-90 min) in the Staged-dose PCI vs. the Single-dose PCI group.

  At 90 min after the first dose enoxaparin is given.

Secondary Outcomes (12)

• Anti-Xa level (CAG-10 min) in the High-dose vs. the Standard-dose group.

  At 10 min after the first dose enoxaparin is given.

• Anti-Xa level (CAG-10 min) in the Staged-dose PCI vs. the Single-dose PCI group.

  At 10 min after the first dose enoxaparin is given.

• Anti-Xa level (PCI-0 min) in the Staged-dose PCI vs. the Single-dose PCI group.

  At 0 min (immediately before) PCI.

• Anti-Xa level (PCI-10 min) in the Staged-dose PCI vs. the Single-dose PCI group.

  At 10 min after the beginning of PCI.

• Anti-Xa level (PCI-End) in the Staged-dose PCI vs. the Single-dose PCI group.

  At the end of PCI.

Other Outcomes (4)

• Major adverse cardiac events (MACE) in the High-dose vs. the Standard-dose group.

  Up to 24 hours.

• Major adverse cardiac events (MACE) in the Staged-dose PCI vs. the Single-dose PCI group.

  Up to 24 hours.

• Thrombolysis in myocardial infarction (TIMI) major or minor bleeding in the High-dose vs. the Standard-dose group.

  Up to 24 hours.

Study Arms (4)

Enoxaparin (Staged-dose PCI Group)

EXPERIMENTAL

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 (Single-dose PCI Group)

ACTIVE COMPARATOR

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 (High-dose Group)

EXPERIMENTAL

Enoxaparin 0.75 mg/kg at the beginning of coronary angiography (i.e., insertion of angiographic catheter).

Drug: Enoxaparin (High-dose Group)

Enoxaparin (Standard-dose Group)

ACTIVE COMPARATOR

Enoxaparin 0.5 mg/kg at the beginning of coronary angiography (i.e., insertion of angiographic catheter).

Drug: Enoxaparin (Standard-dose Group)

Interventions

Enoxaparin (Staged-dose PCI Group) DRUG

Enoxaparin 0.5+0.25 mg/kg administered intravenously.

Also known as: Clexane

Enoxaparin (Staged-dose PCI Group)

Enoxaparin (Single-dose PCI Group) DRUG

Enoxaparin 0.75 mg/kg administered intravenously.

Also known as: Clexane

Enoxaparin (Single-dose PCI Group)

Enoxaparin (High-dose Group) DRUG

Enoxaparin 0.75 mg/kg administered intravenously.

Also known as: Clexane

Enoxaparin (High-dose Group)

Enoxaparin (Standard-dose Group) DRUG

Enoxaparin 0.5 mg/kg administered intravenously.

Also known as: Clexane

Enoxaparin (Standard-dose Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Recent (within 30 days of screening) acute myocardial infarction, including ST-segment elevation myocardial infarction or non-ST-segment elevation myocardial infarction.
• The aim of the index coronary angiography is to undergo primary PCI or early PCI for acute coronary syndromes.
• 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.
• Planned use of any fibrinolytic or antithrombotic agents, with the exception of enoxaparin, aspirin, clopidogrel, and ticagrelor during study period.
• Planned coronary artery bypass graft (CABG) during study period.
• 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.
• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (46)

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MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Enoxaparin; Population Groups

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; Demography; Population Characteristics

Study Officials

• Zhenyu Liu, M.D.

  Department of Cardiology, Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Eligible patients are randomly assigned into the Planned Staged-dose Group and the 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 \[0.75 mg/kg\]).

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: May 9, 2017
• Study Start: May 12, 2017
• Primary Completion: April 20, 2022
• Study Completion: July 14, 2022
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)