Aspirin Versus Aspirin+Clopidogrel as Antithrombotic Treatment Following TAVI

NCT02640794 | Completed Phase 4

• 1 other identifier: ARTE2
• Study Type: interventional
• Target: 222
• Locations: 3 countries
• Sites: 4

Brief Summary

The purpose of this study is to compare aspirin/acetylsalicylic acid+ clopidogrel with aspirin/acetylsalicylic acid alone as antithrombotic treatment following TAVI for the prevention of major ischemic events (MI, ischemic stroke) or death without increasing the risk of major bleeding events.

Conditions

Aortic Valve Disease; Myocardial Infarction; Stroke; Bleeding

Keywords

Transcatheter aortic valve implantation; Antithrombotic treatment; Clopidogrel; Aspirin/acetylsalicylic acid; Myocardial Infarction; Ischemic stroke; Major bleeding

Outcome Measures

Primary Outcomes (1)

• Incidence of death, MI, ischemic stroke/Transient ischemic attack (TIA) or life threatening/major bleeding at 3-month follow-up.

  The composite endpoint of incidence of death, MI, ischemic stroke/Transient ischemic attack (TIA) or life life threatening/major bleeding at 3-month follow-up will be analyzed

  3-month follow-up

Secondary Outcomes (6)

• Incidence of death, MI, ischemic stroke/TIA or life threatening/major bleeding at 30 days

  30 days

• Incidence of death, MI, ischemic stroke/TIA or life threatening/major bleeding at at 12-month follow-up

  12-month follow-up

• Incidence of MI or ischemic stroke at 30 days and at 12-month follow-up

  12-month follow-up

• Cardiovascular death at 30 days and at 12-month follow-up

  30 days and at 12-month follow-up

• Cost-effectiveness of clopidogrel on top of aspirin/acetylsalicylic acid following TAVI

  30 days and at 12-month follow-up

Study Arms (2)

Aspirin +clopidogrel

ACTIVE COMPARATOR

Patients would be randomized within the month prior to the TAVI procedure to receive aspirin/acetylsalicylic acid (80-325 mg/d) + clopidogrel (75 mg/d)

Drug: Clopidogrel; Drug: Aspirin

Aspirin

ACTIVE COMPARATOR

Patients will be randomized within the month prior to the TAVI procedure to receive aspirin/acetylsalicylic acid (80-325 mg/d)

Drug: Aspirin

Interventions

Clopidogrel DRUG

Clopidogrel therapy will start within 24 hrs before the TAVI procedure in cases where a transfemoral approach is used and within 24 hrs after the TAVI procedure in cases where a transapical approach is used. The initial dose of clopidogrel will be of 300 mg followed by 75 mg/die. The duration of clopidogrel treatment will be of 3 months.

Also known as: Plavix

Aspirin +clopidogrel

Aspirin DRUG

Aspirin/acetylsalicylic acid (80-325 mg/d). Aspirin/acetylsalicylic acid therapy will start at least 24 hrs before the TAVI procedure and continued for at least 6 months.

Also known as: Acetylsalicylic acid

Aspirin; Aspirin +clopidogrel

Eligibility Criteria

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

You may qualify if:

• Patients undergoing a TAVI procedure with the Edwards valve.

You may not qualify if:

• Need for chronic anticoagulation treatment
• Major bleeding within the 3 months prior to the TAVI procedure
• Prior intracranial bleeding
• Drug-eluting stent implantation within the year prior to the TAVI procedure
• Allergy to clopidogrel and/or aspirin/acetylsalicylic acid

Sponsors & Collaborators

• Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec: lead

Study Sites (4)

St Michael's Hospital

Toronto, Ontario, Canada

Location

Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Québec, G1V 4G5, Canada

Location

Hospital San Borja Arriaran

Santiago, Chile

Location

Hospital Vall d'Hebron de Barcelona

Barcelona, Spain

Location

Related Publications (12)

• Rodes-Cabau J. [Progress in transcatheter aortic valve implantation]. Rev Esp Cardiol. 2010 Apr;63(4):439-50. Spanish.

  PMID: 20334810 RESULT

• Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.

  PMID: 20961243 RESULT

• Thomas M, Schymik G, Walther T, Himbert D, Lefevre T, Treede H, Eggebrecht H, Rubino P, Michev I, Lange R, Anderson WN, Wendler O. Thirty-day results of the SAPIEN aortic Bioprosthesis European Outcome (SOURCE) Registry: A European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation. 2010 Jul 6;122(1):62-9. doi: 10.1161/CIRCULATIONAHA.109.907402. Epub 2010 Jun 21.

  PMID: 20566953 RESULT

• Rodes-Cabau J, Webb JG, Cheung A, Ye J, Dumont E, Feindel CM, Osten M, Natarajan MK, Velianou JL, Martucci G, DeVarennes B, Chisholm R, Peterson MD, Lichtenstein SV, Nietlispach F, Doyle D, DeLarochelliere R, Teoh K, Chu V, Dancea A, Lachapelle K, Cheema A, Latter D, Horlick E. Transcatheter aortic valve implantation for the treatment of severe symptomatic aortic stenosis in patients at very high or prohibitive surgical risk: acute and late outcomes of the multicenter Canadian experience. J Am Coll Cardiol. 2010 Mar 16;55(11):1080-90. doi: 10.1016/j.jacc.2009.12.014. Epub 2010 Jan 22.

  PMID: 20096533 RESULT

• Gurvitch R, Wood DA, Tay EL, Leipsic J, Ye J, Lichtenstein SV, Thompson CR, Carere RG, Wijesinghe N, Nietlispach F, Boone RH, Lauck S, Cheung A, Webb JG. Transcatheter aortic valve implantation: durability of clinical and hemodynamic outcomes beyond 3 years in a large patient cohort. Circulation. 2010 Sep 28;122(13):1319-27. doi: 10.1161/CIRCULATIONAHA.110.948877. Epub 2010 Sep 13.

  PMID: 20837893 RESULT

• Lip GY, Nieuwlaat R, Pisters R, Lane DA, Crijns HJ. Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: the euro heart survey on atrial fibrillation. Chest. 2010 Feb;137(2):263-72. doi: 10.1378/chest.09-1584. Epub 2009 Sep 17.

  PMID: 19762550 RESULT

• Shehab N, Sperling LS, Kegler SR, Budnitz DS. National estimates of emergency department visits for hemorrhage-related adverse events from clopidogrel plus aspirin and from warfarin. Arch Intern Med. 2010 Nov 22;170(21):1926-33. doi: 10.1001/archinternmed.2010.407.

  PMID: 21098354 RESULT

• ACTIVE Investigators; Connolly SJ, Pogue J, Hart RG, Hohnloser SH, Pfeffer M, Chrolavicius S, Yusuf S. Effect of clopidogrel added to aspirin in patients with atrial fibrillation. N Engl J Med. 2009 May 14;360(20):2066-78. doi: 10.1056/NEJMoa0901301. Epub 2009 Mar 31.

  PMID: 19336502 RESULT

• Hansen ML, Sorensen R, Clausen MT, Fog-Petersen ML, Raunso J, Gadsboll N, Gislason GH, Folke F, Andersen SS, Schramm TK, Abildstrom SZ, Poulsen HE, Kober L, Torp-Pedersen C. Risk of bleeding with single, dual, or triple therapy with warfarin, aspirin, and clopidogrel in patients with atrial fibrillation. Arch Intern Med. 2010 Sep 13;170(16):1433-41. doi: 10.1001/archinternmed.2010.271.

  PMID: 20837828 RESULT

• Delaney JA, Opatrny L, Brophy JM, Suissa S. Drug drug interactions between antithrombotic medications and the risk of gastrointestinal bleeding. CMAJ. 2007 Aug 14;177(4):347-51. doi: 10.1503/cmaj.070186.

  PMID: 17698822 RESULT

• Leon MB, Piazza N, Nikolsky E, Blackstone EH, Cutlip DE, Kappetein AP, Krucoff MW, Mack M, Mehran R, Miller C, Morel MA, Petersen J, Popma JJ, Takkenberg JJ, Vahanian A, van Es GA, Vranckx P, Webb JG, Windecker S, Serruys PW. Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium. Eur Heart J. 2011 Jan;32(2):205-17. doi: 10.1093/eurheartj/ehq406. Epub 2011 Jan 6.

  PMID: 21216739 RESULT

• Rodes-Cabau J, Masson JB, Welsh RC, Garcia Del Blanco B, Pelletier M, Webb JG, Al-Qoofi F, Genereux P, Maluenda G, Thoenes M, Paradis JM, Chamandi C, Serra V, Dumont E, Cote M. Aspirin Versus Aspirin Plus Clopidogrel as Antithrombotic Treatment Following Transcatheter Aortic Valve Replacement With a Balloon-Expandable Valve: The ARTE (Aspirin Versus Aspirin + Clopidogrel Following Transcatheter Aortic Valve Implantation) Randomized Clinical Trial. JACC Cardiovasc Interv. 2017 Jul 10;10(13):1357-1365. doi: 10.1016/j.jcin.2017.04.014. Epub 2017 May 17.

  PMID: 28527771 DERIVED

MeSH Terms

Conditions

Aortic Valve Disease; Myocardial Infarction; Stroke; Hemorrhage; Ischemic Stroke

Interventions

Clopidogrel; Aspirin

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Josep Rodes, MD

  Fondation IUCPQ

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 23, 2015
• First Posted: December 29, 2015
• Study Start: January 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: March 1, 2018
• Last Updated: July 17, 2018

Record last verified: 2018-07

Locations

CA (2); CL (1); ES (1)