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Coronary Artery DiseasePhase 4OPTIENOX-PCINCT03145675

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

A Phase 4 study testing Enoxaparin (Staged-dose PCI Group), Enoxaparin (Single-dose PCI Group) and Enoxaparin (High-dose Group) in people with Coronary Artery Disease and Percutaneous Coronary Intervention, run by Peking Union Medical College Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Enoxaparin (Staged-dose PCI Group), Enoxaparin (Single-dose PCI Group) and Enoxaparin (High-dose Group)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
378 participants
Where
1 siteChina
Study dates
12 May 2017to 14 Jul 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 24Show fewer
  • 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.
  • History of intolerance to enoxaparin.
  • 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.
  • 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.
  • 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.
  • Patients who has previously been randomized in this study.
  • Participation in another investigational drug or device study within 30 days of screening.
  • Involvement in the planning and conduct of the study (applies to investigators, contract research organization staff, and study site staff).
  • Known pregnancy, breast-feeding, or intend to become pregnant during the study period.
  • Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

Other trials in China

About this study

Official title: Optimizing the Anticoagulation Regimen of Enoxaparin During Percutaneous Coronary Intervention

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).

Read the detailed description

Once the radial sheaths are successfully inserted, eligible patients will be consecutively, sequentially, and randomly assigned in a 1:1 ratio and with a block size of 4 to either the Planned Single-dose group (0.75 mg/kg) or the Planned Staged-dose group (0.5 ± 0.25 mg/kg).

The first dose enoxaparin will be administered immediately after randomization. In the Planned Single-dose group, enoxaparin 0.75 mg/kg will be given to all patients before CAG irrespective of whether they will undergo subsequent PCI or not. In the Planned Staged-dose group, enoxaparin 0.5 mg/kg will be administered to all patients before CAG and additional 0.25 mg/kg will be given only to those who will undergo subsequent PCI immediately before PCI.

Trans-radial CAG will be performed immediately after the first dose enoxaparin is given. When the angiographic results are available, whether the patients will proceed to subsequent PCI or not will be at the discretion of the procedure operators, who are blinded to the assignment of enoxaparin dosing regimens. Patients who undergo CAG alone in each group will be defined as the High-dose (0.75 mg/kg) and the Standard-dose (0.5 mg/kg) groups, respectively; while, patients who undergo both CAG and subsequent PCI in each group will be defined as the Single-dose PCI (0.75 mg/kg) and the Staged-dose PCI (0.5 + 0.25 mg/kg) groups, respectively.

Anti-Xa levels will be assessed: 1) at 0 min (immediately before), 10 min and 90 min after the first dose enoxaparin is given (CAG-0 min, CAG-10 min, and CAG-90 min, respectively) in all patients; 2) at 0 min (immediately before) and 10 min after the beginning of PCI (PCI-0 min and PCI-10 min, respectively), and at the end of PCI (PCI-End) in patients undergoing PCI.

Target anticoagulation is defined as: 1) anti-Xa level of 0.5-1.8 IU/ml in patients in the High-dose and Standard-dose groups; 2) anti-Xa level of 0.5-1.2 IU/ml before PCI and anti-Xa level of 0.5-1.8 IU/ml from the beginning of PCI up to 90 min after the first dose enoxaparin is given in the Single-dose PCI and the Staged-dose PCI groups.

The information on cardiac ischemic and bleeding events will be collected 24 h after randomization.

The OPTIENOX-PCI study will assess the anticoagulation profile between: 1) the High-dose and the Standard-dose groups (0.75 mg/kg vs. 0.5 mg/kg); 2) the Staged-dose PCI and the Single-dose PCI groups (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.

Being tested
Enoxaparin (Staged-dose PCI Group), Enoxaparin (Single-dose PCI Group), Enoxaparin (High-dose Group), Enoxaparin (Standard-dose Group)
Keywords
Anticoagulation, Enoxaparin, Dose
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enoxaparin (Staged-dose PCI Group)Drug

    Also called Clexane

    Enoxaparin 0.5+0.25 mg/kg administered intravenously.

  • Enoxaparin (Single-dose PCI Group)Drug

    Also called Clexane

    Enoxaparin 0.75 mg/kg administered intravenously.

  • Enoxaparin (High-dose Group)Drug

    Also called Clexane

    Enoxaparin 0.75 mg/kg administered intravenously.

  • Enoxaparin (Standard-dose Group)Drug

    Also called Clexane

    Enoxaparin 0.5 mg/kg administered intravenously.

Study groups in NCT03145675
Study groupRoleWhat they receive
Enoxaparin (Staged-dose PCI Group)ExperimentalEnoxaparin 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).
Receives: Drug: Enoxaparin (Staged-dose PCI Group)
Enoxaparin (Single-dose PCI Group)Active comparatorEnoxaparin 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).
Receives: Drug: Enoxaparin (Single-dose PCI Group)
Enoxaparin (High-dose Group)ExperimentalEnoxaparin 0.75 mg/kg at the beginning of coronary angiography (i.e., insertion of angiographic catheter).
Receives: Drug: Enoxaparin (High-dose Group)
Enoxaparin (Standard-dose Group)Active comparatorEnoxaparin 0.5 mg/kg at the beginning of coronary angiography (i.e., insertion of angiographic catheter).
Receives: Drug: Enoxaparin (Standard-dose Group)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At 90 min after the first dose enoxaparin is given.

  2. 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.

    Measured: At 90 min after the first dose enoxaparin is given.

Secondary outcomes (12)

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

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

    Measured: At 10 min after the first dose enoxaparin is given.

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

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

    Measured: At 10 min after the first dose enoxaparin is given.

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

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

    Measured: At 0 min (immediately before) PCI.

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

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

    Measured: At 10 min after the beginning of PCI.

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

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

    Measured: At the end of PCI.

  6. Target anticoagulation (CAG-90 min) in the High-dose vs. the Standard-dose group.

    The rate of target anticoagulation (CAG-90 min) in the High-dose vs. the Standard-dose group.

    Measured: At 90 min after the first dose enoxaparin is given.

  7. Target anticoagulation (CAG-90 min) in the Staged-dose PCI vs. the Single-dose PCI group.

    The rate of target anticoagulation (CAG-90 min) in the Staged-dose PCI vs. the Single-dose PCI group.

    Measured: At 90 min after the first dose enoxaparin is given.

  8. Target anticoagulation (CAG-10 min) in the High-dose vs. the Standard-dose group.

    The rate of target anticoagulation (CAG-10 min) in the High-dose vs. the Standard-dose group.

    Measured: At 10 min after the first dose enoxaparin is given.

  9. Target anticoagulation (CAG-10 min) in the Staged-dose PCI vs. the Single-dose PCI group.

    The rate of target anticoagulation (CAG-10 min) in the Staged-dose PCI vs. the Single-dose PCI group.

    Measured: At 10 min after the first dose enoxaparin is given.

  10. Target anticoagulation (PCI-0 min) in the Staged-dose PCI vs. the Single-dose PCI group.

    The rate of target anticoagulation (PCI-0 min) in the Staged-dose PCI vs. the Single-dose PCI group.

    Measured: At 0 min (immediately before) PCI.

  11. Target anticoagulation (PCI-10 min) in the Staged-dose PCI vs. the Single-dose PCI group.

    The rate of target anticoagulation (PCI-10 min) in the Staged-dose PCI vs. the Single-dose PCI group.

    Measured: At 10 min after the beginning of PCI.

  12. Target anticoagulation (PCI-End) in the Staged-dose PCI vs. the Single-dose PCI group.

    The rate of target anticoagulation (PCI-End) in the Staged-dose PCI vs. the Single-dose PCI group.

    Measured: At the end of PCI.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2017
  2. Study start12 May 2017
  3. Primary completion20 Apr 2022
  4. Study completion14 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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 \[0.75 mg/kg\]).
Masking
None (open label)
Enrolment
378 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03145675
Sponsor's protocol ID
PUMCH-2016-2.24
Other IDs
JS-1286
Acronym
OPTIENOX-PCI
Status last verified
Oct 2022
First submitted
14 Apr 2017
Last updated
12 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Amsterdam EA, Wenger NK, Brindis RG, Casey DE Jr, Ganiats TG, Holmes DR Jr, Jaffe AS, Jneid H, Kelly RF, Kontos MC, Levine GN, Liebson PR, Mukherjee D, Peterson ED, Sabatine MS, Smalling RW, Zieman SJ; ACC/AHA Task Force Members; Society for Cardiovascular Angiography and Interventions and the Society of Thoracic Surgeons. 2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Dec 23;130(25):2354-94. doi: 10.1161/CIR.0000000000000133. Epub 2014 Sep 23. No abstract available.

    PubMed 25249586

  • Argenti D, Hoppensteadt D, Heald D, Jensen B, Fareed J. Pharmacokinetics of enoxaparin in patients undergoing percutaneous coronary intervention with and without glycoprotein IIb/IIIa therapy. Am J Ther. 2003 Jul-Aug;10(4):241-6. doi: 10.1097/00045391-200307000-00002.

    PubMed 12845386

  • Bernat I, Horak D, Stasek J, Mates M, Pesek J, Ostadal P, Hrabos V, Dusek J, Koza J, Sembera Z, Brtko M, Aschermann O, Smid M, Polansky P, Al Mawiri A, Vojacek J, Bis J, Costerousse O, Bertrand OF, Rokyta R. ST-segment elevation myocardial infarction treated by radial or femoral approach in a multicenter randomized clinical trial: the STEMI-RADIAL trial. J Am Coll Cardiol. 2014 Mar 18;63(10):964-72. doi: 10.1016/j.jacc.2013.08.1651. Epub 2013 Nov 21.

    PubMed 24211309

  • Caputo RP, Tremmel JA, Rao S, Gilchrist IC, Pyne C, Pancholy S, Frasier D, Gulati R, Skelding K, Bertrand O, Patel T. Transradial arterial access for coronary and peripheral procedures: executive summary by the Transradial Committee of the SCAI. Catheter Cardiovasc Interv. 2011 Nov 15;78(6):823-39. doi: 10.1002/ccd.23052. Epub 2011 May 4.

    PubMed 21544927

  • Chen WH, Lau CP, Lau YK, Ng W, Lee PY, Yu CM, Ma E. Stable and optimal anticoagulation is achieved with a single dose of intravenous enoxaparin in patients undergoing percutaneous coronary intervention. J Invasive Cardiol. 2002 Aug;14(8):439-42.

    PubMed 12147872

  • Chew DP, Bhatt DL, Lincoff AM, Moliterno DJ, Brener SJ, Wolski KE, Topol EJ. Defining the optimal activated clotting time during percutaneous coronary intervention: aggregate results from 6 randomized, controlled trials. Circulation. 2001 Feb 20;103(7):961-6. doi: 10.1161/01.cir.103.7.961.

    PubMed 11181470

  • Choussat R, Montalescot G, Collet JP, Vicaut E, Ankri A, Gallois V, Drobinski G, Sotirov I, Thomas D. A unique, low dose of intravenous enoxaparin in elective percutaneous coronary intervention. J Am Coll Cardiol. 2002 Dec 4;40(11):1943-50. doi: 10.1016/s0735-1097(02)02531-7.

    PubMed 12475453

  • Cohen M. The role of low-molecular-weight heparin in the management of acute coronary syndromes. J Am Coll Cardiol. 2003 Feb 19;41(4 Suppl S):55S-61S. doi: 10.1016/s0735-1097(02)02901-7.

    PubMed 12644342

  • Collet JP, Montalescot G, Lison L, Choussat R, Ankri A, Drobinski G, Sotirov I, Thomas D. Percutaneous coronary intervention after subcutaneous enoxaparin pretreatment in patients with unstable angina pectoris. Circulation. 2001 Feb 6;103(5):658-63. doi: 10.1161/01.cir.103.5.658.

    PubMed 11156876

  • Feldman DN, Swaminathan RV, Kaltenbach LA, Baklanov DV, Kim LK, Wong SC, Minutello RM, Messenger JC, Moussa I, Garratt KN, Piana RN, Hillegass WB, Cohen MG, Gilchrist IC, Rao SV. Adoption of radial access and comparison of outcomes to femoral access in percutaneous coronary intervention: an updated report from the national cardiovascular data registry (2007-2012). Circulation. 2013 Jun 11;127(23):2295-306. doi: 10.1161/CIRCULATIONAHA.112.000536.

    PubMed 23753843

  • Ferguson JJ, Dougherty KG, Gaos CM, Bush HS, Marsh KC, Leachman DR. Relation between procedural activated coagulation time and outcome after percutaneous transluminal coronary angioplasty. J Am Coll Cardiol. 1994 Apr;23(5):1061-5. doi: 10.1016/0735-1097(94)90590-8.

    PubMed 8144768

  • Ferrante G, Rao SV, Juni P, Da Costa BR, Reimers B, Condorelli G, Anzuini A, Jolly SS, Bertrand OF, Krucoff MW, Windecker S, Valgimigli M. Radial Versus Femoral Access for Coronary Interventions Across the Entire Spectrum of Patients With Coronary Artery Disease: A Meta-Analysis of Randomized Trials. JACC Cardiovasc Interv. 2016 Jul 25;9(14):1419-34. doi: 10.1016/j.jcin.2016.04.014. Epub 2016 Jun 29.

    PubMed 27372195

  • Giugliano RP, White JA, Bode C, Armstrong PW, Montalescot G, Lewis BS, van 't Hof A, Berdan LG, Lee KL, Strony JT, Hildemann S, Veltri E, Van de Werf F, Braunwald E, Harrington RA, Califf RM, Newby LK; EARLY ACS Investigators. Early versus delayed, provisional eptifibatide in acute coronary syndromes. N Engl J Med. 2009 May 21;360(21):2176-90. doi: 10.1056/NEJMoa0901316. Epub 2009 Mar 30.

    PubMed 19332455

  • Gurm HS, Hosman C, Share D, Moscucci M, Hansen BB; Blue Cross Blue Shield of Michigan Cardiovascular Consortium. Comparative safety of vascular closure devices and manual closure among patients having percutaneous coronary intervention. Ann Intern Med. 2013 Nov 19;159(10):660-6. doi: 10.7326/0003-4819-159-10-201311190-00004.

    PubMed 24247671

  • Hirsh J, Raschke R. Heparin and low-molecular-weight heparin: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004 Sep;126(3 Suppl):188S-203S. doi: 10.1378/chest.126.3_suppl.188S.

    PubMed 15383472

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Enoxaparin (Staged-dose PCI Group), Enoxaparin (Single-dose PCI Group) and Enoxaparin (High-dose Group) in people with Coronary Artery Disease and Percutaneous Coronary Intervention, run by Peking Union Medical College Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anti-Xa level (CAG-90 min) in the High-dose vs. the Standard-dose group. (time frame: At 90 min after the first dose enoxaparin is given.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03145675, which also lists 47 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.

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