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Trial record 81 of 617 for:    ASPIRIN AND clopidogrel

Impact of Hybrid Coronary Revascularization on Antiplatelet Therapy

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ClinicalTrials.gov Identifier: NCT02293928
Recruitment Status : Completed
First Posted : November 19, 2014
Last Update Posted : November 19, 2014
Sponsor:
Collaborators:
Danish Heart Foundation
Aase and Ejnar Danielsens Foundation
Information provided by (Responsible Party):
Ivy Modrau, Aarhus University Hospital Skejby

Brief Summary:

The effect of antiplatelet therapy is impaired among patients, who recently underwent on-pump coronary artery bypass grafting. The impact of hybrid coronary revascularization using minimal invasive surgical techniques on the antiplatelet effect of aspirin and clopidogrel remains unclear.

The aim of the study is to describe the impact of hybrid coronary revascularization on the effect of aspirin and clopidogrel. Furthermore, we will investigate whether high baseline platelet aggregation, high postoperative levels of platelet turnover and acute-phase response may contribute to the effect.


Condition or disease Intervention/treatment
Coronary Artery Disease Procedure: Hybrid coronary revascularization

Detailed Description:

Objective:

The effect of antiplatelet therapy is impaired among patients, who recently underwent on-pump coronary artery bypass grafting. The impact of hybrid coronary revascularization using minimal invasive surgical techniques on the antiplatelet effect of aspirin and clopidogrel remains unclear.

We hypothesize that hybrid coronary revascularization is associated with a transiently reduced antiplatelet effect of aspirin and clopidogrel. We hypothesize that the reduced antiplatelet effect of aspirin and clopidogrel could be explained by increased platelet turnover with an increased fraction of immature platelets in the peripheral blood. Furthermore, we hypothesize that the reduced antiplatelet effect is associated with increased inflammatory markers in the early postoperative phase. We hypothesize, that high platelet aggregation prior to the intervention is associated with reduced effect of antiplatelet therapy following hybrid coronary revascularization.

Methods:

40 patients with coronary artery disease will be enrolled in this prospective cohort study (recruited from a prospective pilot study conducted to assess feasibility and safety of hybrid coronary revascularization combining minimally invasive off-pump coronary artery bypass grafting through an inferior J-hemisternotomy (JOPCAB) with percutaneous coronary intervention - Clinicaltrials.gov identifier: NCT01496664). Demographics and medical history are documented preoperatively. The predicted mortality is assessed by means of the logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) I. Adverse cardiovascular events are recorded prospectively, including graft dysfunction, myocardial infarction, stroke, and pulmonary embolism.

Six blood samples are obtained from each patient:

  • Pre-OP: in the outpatient setting while patients were on aspirin 75 mg daily
  • Baseline: in the morning prior to surgery after eight to ten days of aspirin discontinuation (off-aspirin)
  • Post-OP: on the first postoperative day when aspirin had been resumed
  • Pre-PCI: on the day prior to PCI
  • Post-PCI: on the first day after PCI following initiation of dual antiplatelet therapy
  • 1-year follow-up: when patients were still on maintenance aspirin 75 mg and clopidogrel 75 mg Platelet function analyses are performed using Multiplate® Analyzer (Roche, Roche Diagnostics, Mannheim, Germany), VerifyNow® Aspirin, and VerifyNow® P2Y12 (Accumetrics Inc., San Diego, CA, USA). For Multiplate® Analyzer, arachidonic acid (1.0 mM) and adenosine diphosphate (6.4 and 20 uM) are used as agonists.

Complete blood counts, including immature platelet fraction (IPF), immature platelet count (IPC), and mean platelet volume (MPV), are performed using a Sysmex XE-5000 haematology analyzer (Sysmex, Kobe, Japan) with upgraded software (XE IPF Master, Sysmex) enabling flow cytometric detection of the IPF. Enzyme-linked immunosorbent assays are used according to the manufacturers' instructions to measure serum thromboxane B2 (Cayman Chemical, Ann Arbor, MI, USA) and thrombopoietin (R&D Systems Europe, Abingdon, UK). Plasma C-reactive protein was measured by immunoprecipitation using the Cobas® 6000 (Roche, Basel, Switzerland). Von Willebrand factor (antigen) and coagulation factor VIII (functional) are measured using the ACL TOP (ILS Laboratories, Bedford, MA, USA).


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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Hybrid Coronary Revascularization on Antiplatelet Effect of Aspirin and Clopidogrel
Study Start Date : October 2010
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Elective hybrid coronary revascularization
All patients are treated with non-enteric coated aspirin 75 mg once daily prior to study participation. Aspirin treatment is discontinued 8-10 days prior to surgery and resumed 6-9 hours after surgery. Left internal mammary grafting of the left descendent coronary artery is performed off-pump through an inferior J-hemisternotomy (JOPCAB). All patients receive an oral loading dose of aspirin 300 mg 6-9 hours after surgery followed by daily maintenance doses of 75 mg aspirin. An oral loading dose of clopidogrel 300 mg 12 hours prior to PCI is followed by daily maintenance doses of 75 mg for 12 months. Patients are followed for 1 year.
Procedure: Hybrid coronary revascularization
Hybrid coronary revascularization with standard double antiplatelet therapy




Primary Outcome Measures :
  1. Change in aspirin antiplatelet effect from preoperative to three days postoperative [ Time Frame: 12-14 days ]
    Platelet aggregation measured by VerifyNow® Aspirin and Multiplate® Analyzer


Secondary Outcome Measures :
  1. Change on aspirin antiplatelet effect from 3 days postoperative to 1 year follow-up [ Time Frame: 1 year ]
    Platelet aggregation measured by VerifyNow® Aspirin and Multiplate® Analyzer

  2. Change on clopidogrel antiplatelet effect from first day after PCI to 1 year follow-up [ Time Frame: 1 year ]
    Platelet aggregation measured by VerifyNow®P2Y12 and Multiplate® Analyzer

  3. Association between baseline platelet aggregation (off-aspirin) and aspirin antiplatelet effect [ Time Frame: 12-14 days ]
    Platelet aggregation measured by VerifyNow® Aspirin and Multiplate® Analyzer Baseline aggregation is compared to aggragation preoperatively (on maintenance aspirin treatment) and postoperatively (when aspirin is resumed).

  4. Correlation between acute phase reactants and platelet aggregation [ Time Frame: 8-10 days preoperative until 1 year postoperative ]
    C-reactive protein, von Willebrand factor (antigen), and coagulation factor VIII (functional)

  5. Correlation between platelet turnover and platelet aggregation [ Time Frame: 8-10 days preoperative until 1 year postoperative ]
    Platelet turnover assessed by Complete blood counts, including immature platelet fraction, immature platelet count, mean platelet volume and thrombopoietin.


Other Outcome Measures:
  1. Compliance to aspirin treatment at enrollment [ Time Frame: 8-10 days preoperative ]
    measured by levels of serum thromboxane B2 below 30 ng/ml

  2. Compliance to aspirin treatment at 1 year follow-up [ Time Frame: 1 year ]
    measured by levels of serum thromboxane B2 below 30 ng/ml


Biospecimen Retention:   Samples Without DNA
4 ml serum and 4 ml sodium citrate plasma


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with coronary artery disease scheduled for elective hybrid coronary revascularization. The study cohort is recruited from a prospective pilot study conducted to assess feasibility and safety of hybrid coronary revascularization combining minimally invasive off-pump coronary artery bypass grafting and percutaneous coronary intervention (PCI) performed three to five days later (Clinicaltrials.gov identifier: NCT01496664).
Criteria

Inclusion Criteria:

  • symptomatic multivessel coronary artery disease
  • treatment with non-enteric coated aspirin 75 mg once daily

Exclusion Criteria:

  • aspirin or clopidogrel intolerance
  • conditions prohibitive of aspirin discontinuation prior to surgery
  • use of anticoagulants or any drugs other than aspirin known to affect platelet function
  • use of immunosuppressive drugs
  • platelet count <100 or >450 x 109/l
  • inability to give informed consent

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): NCT02293928


Locations
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Denmark
Aarhus University Hospital
Aarhus, Denmark, 8200
Sponsors and Collaborators
Aarhus University Hospital Skejby
Danish Heart Foundation
Aase and Ejnar Danielsens Foundation
Investigators
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Principal Investigator: Ivy S Modrau, MD, DMSc Aarhus University Hospitak Skejby

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ivy Modrau, Junior Consultant, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier: NCT02293928     History of Changes
Other Study ID Numbers: 10-000439
First Posted: November 19, 2014    Key Record Dates
Last Update Posted: November 19, 2014
Last Verified: November 2014
Keywords provided by Ivy Modrau, Aarhus University Hospital Skejby:
Hybrid coronary revascularization
Antiplatelet therapy
Aspirin
Clopidogrel
Additional relevant MeSH terms:
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Aspirin
Clopidogrel
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents