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IRCT20230729058953N1 IRCT 2023-08-06 Mashhad University of Medical Sciences عنوان پژوهش به انگليسي: (حداکثر 2 خط)Aspirin versus dual antiplatelet therapy-aspirin and clopidogrel- in patients with minor acute ischemic stroke receiving intravenous thrombolytic therapy: a double blind randomized clinical trial عنوان پژوهش به انگليسي: (حداکثر 2 خط)Aspirin versus dual antiplatelet therapy-aspirin and clopidogrel- in patients with minor acute ischemic stroke receiving intravenous thrombolytic therapy: a double blind randomized clinical trial 2023-08-01 anticipated 180 Complete https://irct.ir/trial/71661 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: According to two intervention groups, the volume of each block will be four. Then the list of blocks is written, and the numbers are assigned to them. For example, (AABB(1)- ABAB (2)-ABBA (3)- BBAA(4)- BABA(5)- BAAB(6)) - depending on the sample size of 180 people, 45 blocks will collect. The random numbers between one and 6 are then selected according to the Randomaize.com randomization site. Finally, the treatment assignment list is written based on random numbers on envelopes containing each block, Blinding description: Due to the use of placebo similar to interventional therapy, the physician associated with the participants and the participants will not be informed of the allocated treatment. The analyst will also be unaware of the treatment allocated to the two groups. Finally, after analyzing the data, the researcher who prepared the packaging reveals the A and B codes. Apart from the pharmacist, none of the participants, researchers, and analysts will know about the drug or placebo until the end of the study. Use of SNOSE sealed non-transparent letters (sequentially numbered, opaque, sealed envelopes) In this way, the envelopes will be prepared and printed by a team member and random numbers and placed inside the envelope. The envelopes will be closed and the contents will not be visible from the outside. Then, first, the purpose of the study is explained to the person who has the mentioned conditions and if the person wishes to sign the informed consent form and remove an envelope, then open it and enter the intervention or control group based on the contents of the envelope. 3 ischemic cerebrovascular attack. Intervention 1: "Intervention group 1": patients entering the study who are treated with aspirin 80 mg once a day and placebo once a day for 21 days. Intervention 2: "Intervention group 2": patients entering the study who are treated with aspirin 80 mg once a day and clopidogrel 75 mg once a day for 21 days. Yes - There is a plan to make this available What will be shared: Part of the data, such as information on the main outcome, can be shared. When: Access to the data is possible 6 months after the results are published. To whom: The data will be available for use by researchers. Conditions: If used as clinical research, it will be available. Where to obtain: Bahram Zarmehri Zarmehrib@mums.ac.ir How to obtain: The request will be reviewed within 30 days Comments:
public Bahram Zarmehri
Ahmadabad blvd, Ghaem Hospital
Mashhad Iran (Islamic Republic of) 9176755535 +98 51 3852 5312 zarmehrib@mums.ac.ir Mashhad University of Medical Sciences scientific Bahram Zarmehri
Ahmadabad Blvd, Ghaem Hospital
Mashhad Iran (Islamic Republic of) 9176755535 +98 51 3852 5312 zarmehrib@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Over the age of 18 years individuals with acute ischemic stroke symptoms of disabling with NIHSS less than 5 which are not prohibited for receiving venous thrombolysis and double antiplatelet (aspirin and clopidogrel combination) according to the protocol. 18 years no limit Both Patients with atrial fibrillation(AF) rhythm A patient who is already on dual antiplatelet therapy ICH (intracranial hemorrhage) symptomatic after receiving intravenous thrombolysis. Treatment - Drugs Treatment - Drugs "Intervention group 1": patients entering the study who are treated with aspirin 80 mg once a day and placebo once a day for 21 days. "Intervention group 2": patients entering the study who are treated with aspirin 80 mg once a day and clopidogrel 75 mg once a day for 21 days. Comparison of the treatment effect of aspirin and clopidogrel and aspirin alone in ischemic stroke patients after intravenous thrombolytic therapy. Timepoint: 24 hours later, 3, 7 and 90 days after the stroke, evaluations are done. Method of measurement: Brain CT scan, modified ranking scale (mRS), neurology specialist visit. Mashhad University of Medical Sciences Approved 2023-07-04 Ethic committee of Mashhad University of Medical sciences Ahmadabad Blvd, Ghaem Hospital Mashhad Razavi Khorasan Iran (Islamic Republic of)