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Safety and Effectiveness of Ticagrelor in Patients Undergoing Carotid Stenting

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ClinicalTrials.gov Identifier: NCT04091074
Recruitment Status : Not yet recruiting
First Posted : September 16, 2019
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Osama Ibrahim Aboelfath Ibrahim, Assiut University

Brief Summary:
patients undergoing carotid stenting take dual anti platelet therapy to prevent thrombotic complications usually used drugs are aspirin plus clopidogrel but there are patients not respond so ticagrelor may be an effective and safe alternative

Condition or disease Intervention/treatment Phase
Carotid Stenosis Drug: Ticagrelor Drug: Clopidogrel Procedure: Carotid stenting Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Effectiveness of Ticagrelor in Patients Undergoing Carotid Stenting
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: aspirin + ticagrelor before carotid stenting
patients undergoing carotid stenting take aspirin 150 mg + ticagrelor 90mg for 15 days before carotid stenting
Drug: Ticagrelor
Half of patients undergoing carotid stenting take ticagrelor+aspirin

Procedure: Carotid stenting
Patients with carotid stenosis will undergo carotid stenting

Active Comparator: aspirin + clopidogrel before carotid stenting
patients undergoing carotid stenting take aspirin 150 mg + clopidogrel 75 mg for 15 days before carotid stenting
Drug: Clopidogrel
Other half ofpatients undergoing carotid stenting take clopidogrel+aspirin

Procedure: Carotid stenting
Patients with carotid stenosis will undergo carotid stenting




Primary Outcome Measures :
  1. compare efficacy of ticagrelor and clopidogrel in patients undergoing carotid stenting [ Time Frame: 15 days before carotid stenting ]
    patients undergoing carotid stenting are divided into 2 groups comparing efficacy of ticagrelor and clopidogrel

  2. Compare safety of ticagrelor and clopidogrel in patients undergoing carotid stenting [ Time Frame: 15 days before carotid stenting ]
    Patients undergoing carotid stenting are divided into two groups comparing safety of ticagrelor and clopidogrel


Secondary Outcome Measures :
  1. Pattern of carotid stenosis [ Time Frame: 1 year ]
    Incidence of carotid stenosis in patients come to Assiut university hospitals



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Ischemis stroke of both sex.
  2. More than 18 years.
  3. Accepting all study requirements.

Exclusion Criteria:

  1. Refuse to comply with all study requirements.
  2. bleeding tendency or liver diseases

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Responsible Party: Osama Ibrahim Aboelfath Ibrahim, Assiut University
ClinicalTrials.gov Identifier: NCT04091074     History of Changes
Other Study ID Numbers: Ticagrelor in carotid stenting
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Aspirin
Clopidogrel
Ticagrelor
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