Impact of Hybrid Coronary Revascularization on Antiplatelet Therapy

NCT02293928 | Completed

• 1 other identifier: 10-000439
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Hybrid coronary revascularization; Antiplatelet therapy; Aspirin; Clopidogrel

Outcome Measures

Primary Outcomes (1)

• Change in aspirin antiplatelet effect from preoperative to three days postoperative

  Platelet aggregation measured by VerifyNow® Aspirin and Multiplate® Analyzer

  12-14 days

Secondary Outcomes (5)

• Change on aspirin antiplatelet effect from 3 days postoperative to 1 year follow-up

  1 year

• Change on clopidogrel antiplatelet effect from first day after PCI to 1 year follow-up

  1 year

• Association between baseline platelet aggregation (off-aspirin) and aspirin antiplatelet effect

  12-14 days

• Correlation between acute phase reactants and platelet aggregation

  8-10 days preoperative until 1 year postoperative

• Correlation between platelet turnover and platelet aggregation

  8-10 days preoperative until 1 year postoperative

Other Outcomes (2)

• Compliance to aspirin treatment at enrollment

  8-10 days preoperative

• Compliance to aspirin treatment at 1 year follow-up

  1 year

Study Arms (1)

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

Interventions

Hybrid coronary revascularization PROCEDURE

Hybrid coronary revascularization with standard double antiplatelet therapy

Elective hybrid coronary revascularization

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aarhus University Hospital Skejby: lead
• Danish Heart Foundation: collaborator
• Aase and Ejnar Danielsens Foundation: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Related Publications (1)

• Modrau IS, Wurtz M, Kristensen SD, Hvas AM. Reduced Effect of Aspirin and Clopidogrel Following Hybrid Coronary Revascularization. Clin Appl Thromb Hemost. 2015 Oct;21(7):603-11. doi: 10.1177/1076029615573304. Epub 2015 Mar 9.

  PMID: 25753965 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

4 ml serum and 4 ml sodium citrate plasma

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Ivy S Modrau, MD, DMSc

  Aarhus University Hospitak Skejby

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Consultant

Study Record Dates

• First Submitted: November 13, 2014
• First Posted: November 19, 2014
• Study Start: October 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: November 19, 2014

Record last verified: 2014-11

Locations

DK (1)