Dual AntiPlatelet Therapies for Prevention of Periinterventional Embolic Events in TAVI

NCT03001960 | Unknown Phase 3

• 1 other identifier: DAPT-TAVI 01
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

TAVI is increasingly adopted as standard treatment for many subgroups of patients with aortic stenosis. However, due to a lack of data there is yet no TAVI-specific guidance regarding the optimum periinterventional drug regimen. The study evaluates the effect of dual antiplatelet pretreatment on periinterventional embolic cerebral lesions and bleeding complications in patients undergoing transfemoral aortic valve implantation (TF-TAVI).

Conditions

Aortic Valve Stenosis; Transcatheter Aortic Valve Replacement; Intracranial Embolism

Outcome Measures

Primary Outcomes (1)

• Total volume of new cerebral lesions on MRI after TAVI versus Baseline

  Total volume of new cerebral lesions on MRI, 24-72h after TAV versus Baseline

Secondary Outcomes (7)

• New lesion volume of cerebral embolization in patients treated with ASS and Clopidogrel before versus after TAVI

  24-72h post TAVI versus baseline

• location of new cerebral lesions early AFTER TAVI

  24-72h after TAVI

• extent of new cerebral lesions early AFTER TAVI

  24-72h after TAVI

• Assessment of different neurocognitive tests before and after TAVI procedure

  24-72 h after TAVI

• Extent of clinically apparent non-cerebral emboli after TAVI

  24-72 h after TAVI

Study Arms (2)

Group 1- PREloading BEFORE TAVI

EXPERIMENTAL

* Aspirin 100 mg loading orally 6-12 hours before TAVI and * Clopidogrel 600mg loading 6-12 before TAVI followed by maintenance dose of 100mg aspirin and 75mg clopidogrel per day

Drug: Preloading before TAVI

Group 2 - POSTLoading AFTER TAVI

EXPERIMENTAL

* Aspirin 100 mg loading orally 6-12 hours after TAVI and * Clopidogrel 600mg loading 6-12 hours after TAVI followed by maintenance dose of 100mg aspirin and 75mg clopidogrel per day

Drug: Postloading after TAVI

Interventions

Preloading before TAVI DRUG

Preloading with Aspirin and Clopidogrel before TAVI

Also known as: ASS, Plavix

Group 1- PREloading BEFORE TAVI

Postloading after TAVI DRUG

Postloading with Aspirin and Clopidogrel after TAVI

Also known as: ASS, Plavix

Group 2 - POSTLoading AFTER TAVI

Eligibility Criteria

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

You may qualify if:

• Patients \>18 years and \<90 years
• Patients undergoing TF-TAVI for severe aortic stenosis (combined with aortic regurgitation)
• Informed consent

You may not qualify if:

• TIA/Stroke within last 90 days
• Aortic valve-in-valve procedures
• TAVI for treatment of isolated aortic regurgitation
• known significant carotid stenosis (\>70%)
• Prior myocardial infarction or revascularization with PCI or CABG within past 3 months
• Clopidogrel and/ or Aspirin within past 7 days
• any other indication for (dual) antiplatelet therapy
• Contraindication to MRI (MRI conditional pacemakers accepted!)
• participation in another interventional trial
• cardiogenic shock (positive shock index OR need for catecholamine support OR systolic bloodpressure \< 90 mmHg) or need for pre-hospital intubation
• cardiac arrest \<90 days prior to randomization
• Pregnant or lactating females

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Prof. Dr. Jochen Fiebach, Center for Stroke Research Berlin (CSB), Charité - Universitaetsmedizin Berlin: collaborator

Related Publications (2)

• Holmes DR Jr, Brennan JM, Rumsfeld JS, Dai D, O'Brien SM, Vemulapalli S, Edwards FH, Carroll J, Shahian D, Grover F, Tuzcu EM, Peterson ED, Brindis RG, Mack MJ; STS/ACC TVT Registry. Clinical outcomes at 1 year following transcatheter aortic valve replacement. JAMA. 2015 Mar 10;313(10):1019-28. doi: 10.1001/jama.2015.1474.

  PMID: 25756438 BACKGROUND

• Osnabrugge RL, Mylotte D, Head SJ, Van Mieghem NM, Nkomo VT, LeReun CM, Bogers AJ, Piazza N, Kappetein AP. Aortic stenosis in the elderly: disease prevalence and number of candidates for transcatheter aortic valve replacement: a meta-analysis and modeling study. J Am Coll Cardiol. 2013 Sep 10;62(11):1002-12. doi: 10.1016/j.jacc.2013.05.015. Epub 2013 May 30.

  PMID: 23727214 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis; Intracranial Embolism

Interventions

Argininosuccinate Synthase; Clopidogrel

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Intracranial Embolism and Thrombosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Thromboembolism; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Carbon-Nitrogen Ligases; Ligases; Enzymes; Enzymes and Coenzymes; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: December 18, 2016
• First Posted: December 23, 2016
• Study Start: March 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: April 1, 2018
• Last Updated: December 28, 2016

Record last verified: 2016-12