The Effect Of Ticagrelor On Saphenous Vein Graft Patency In Patients Undergoing Coronary Artery Bypass Grafting Surgery

NCT02352402 | Unknown Phase 3 DMC

• 2 other identifiers: POPCABG2014-002142-50
• Study Type: interventional
• Target: 487
• Locations: 1 country
• Sites: 6

Brief Summary

In the POPular CABG study we investigate if the addition of ticagrelor, a drug that inhibits blood platelets from clotting, to treatment with aspirin will reduce the rate of saphenous vein graft occlusion as assessed with coronary computed tomography angiography at 1 year after coronary artery bypass grafting surgery.

Conditions

Coronary Artery Disease; Stable Angina; Acute Coronary Syndrome

Keywords

CABG; Ticagrelor; Graft; Patency

Outcome Measures

Primary Outcomes (1)

• Saphenous vein graft occlusion

  As assessed with coronary computed tomography angiography or clinically indicated coronary angiography

  1 year after coronary artery bypass grafting

Secondary Outcomes (15)

• Saphenous vein graft failure

  1 year after coronary artery bypass grafting

• Significant saphenous vein graft stenosis

  1 year after coronary artery bypass grafting

• BARC minor (type 1 or 2) and major (type 3, 4 or 5) bleeding

  30 days after coronary artery bypass grafting

• BARC minor (type 1 or 2) and major (type 3, 4 or 5) bleeding

  1 year after coronary artery bypass grafting

• TIMI minor and major bleeding

  30 days after coronary artery bypass grafting

Study Arms (2)

Ticagrelor

EXPERIMENTAL

Ticagrelor 90mg twice daily for 1 year on top of ASA

Drug: Ticagrelor

Placebo

PLACEBO COMPARATOR

Placebo matching ticagrelor 90mg twice daily on top of ASA

Drug: Placebo

Interventions

Ticagrelor DRUG

Also known as: Brilique, Brillinta

Ticagrelor

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• More than 21 years of age
• Planned coronary artery bypass grafting (CABG) with the use of 1 or more saphenous vein grafts, CABG being an isolated procedure or part of a combined aortic valce replacement surgery with bioprothesis.

You may not qualify if:

• Unable to give informed consent or a life expectancy of less than 1 year
• Concomitant valve, aorta or rhythm surgery during the same session, (excluding aortic bioprothesis)
• Inability to undergo coronary computed tomography angiography, in the investigator's opinion, for instance due to severe claustrophobia or contrast allergy
• Use of oral anticoagulants (acenocoumarol, phenprocoumon, dabigatran, rivaroxaban, etc) and a contraindication for discontinuation of this medication or the expectation that the patient will have an indication for the use of these drugs after surgery
• Placement of a drug-eluting stent in a coronary or cerebral artery within 6 months of CABG or placement of a bare-metal stent in a coronary or cerebral artery within 1 month of CABG
• Use of antiplatelet drugs other than aspirin (clopidogrel, prasugrel, ticagrelor, dipyridamol, etc.) and a contraindication for discontinuation of this medication after CABG, according to the treating physician or the investigator
• Women who are known to be pregnant, who have given birth within the past 90 days or who are breastfeeding
• Pre-menopausal women without adequate contraception
• Severe renal function impairment requiring dialysis
• Moderate or severe hepatic impairment
• Active malignancy with increase in bleeding risk, in the investigator's opinion
• Use of strong inhibitors of CYP3A4 (e.g. ketaconazole, clarithromycin, nefazodone, ritonavir, atazanavir)
• Clinically significant out of range values for platelet count or haemoglobin at screening, in the investigator's opinion
• Contraindication for the use of ticagrelor or aspirin (i.e. history of intracranial bleeding, high bleeding risk, previous allergic reaction), in the investigator's opinion

Sponsors & Collaborators

• J.M. ten Berg: lead
• AstraZeneca: collaborator

Study Sites (6)

St Antonius Hospital

Nieuwegein, Utrecht, 3435CM, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, 5623 EJ, Netherlands

Location

Medisch Spectrum Twente

Enschede, Netherlands

Location

Universitair Medisch Centrum Groningen

Groningen, Netherlands

Location

Radboud UMC

Nijmegen, Netherlands

Location

Erasmus Erasmus UMC

Rotterdam, Netherlands

Location

Related Publications (3)

• Willemsen LM, Janssen PWA, Hackeng CM, Kelder JC, Tijssen JGP, van Straten AHM, Soliman-Hamad MA, Deneer VHM, Daeter EJ, Sonker U, Klein P, Ten Berg JM. A randomized, double-blind, placebo-controlled trial investigating the effect of ticagrelor on saphenous vein graft patency in patients undergoing coronary artery bypass grafting surgery-Rationale and design of the POPular CABG trial. Am Heart J. 2020 Feb;220:237-245. doi: 10.1016/j.ahj.2019.12.001. Epub 2019 Dec 13.

  PMID: 31884246 BACKGROUND

• Willemsen LM, Janssen PWA, Peper J, Soliman-Hamad MA, van Straten AHM, Klein P, Hackeng CM, Sonker U, Bekker MWA, von Birgelen C, Brouwer MA, van der Harst P, Vlot EA, Deneer VHM, Chan Pin Yin DRPP, Gimbel ME, Beukema KF, Daeter EJ, Kelder JC, Tijssen JGP, Rensing BJWM, van Es HW, Swaans MJ, Ten Berg JM. Effect of Adding Ticagrelor to Standard Aspirin on Saphenous Vein Graft Patency in Patients Undergoing Coronary Artery Bypass Grafting (POPular CABG): A Randomized, Double-Blind, Placebo-Controlled Trial. Circulation. 2020 Nov 10;142(19):1799-1807. doi: 10.1161/CIRCULATIONAHA.120.050749. Epub 2020 Aug 31.

  PMID: 32862716 DERIVED

• Feitosa MPM, Soffiatti CD, Linhares Filho JPP, Batista DV, Lobo Filho HG, Lima EG, Serrano Junior CV. Dual platelet antiaggregation therapy after myocardial revascularization surgery. Rev Assoc Med Bras (1992). 2019 Mar;65(3):316-318. doi: 10.1590/1806-9282.65.3.316. Epub 2019 Apr 11.

  PMID: 30994825 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Angina, Stable; Acute Coronary Syndrome

Interventions

Ticagrelor

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Jurriën M ten Berg, MD, PhD

  St. Antonius Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD, FESC, FACC

Study Record Dates

• First Submitted: September 19, 2014
• First Posted: February 2, 2015
• Study Start: March 1, 2015
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: April 27, 2020

Record last verified: 2020-04

Locations

NL (6)