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
Is double antiplatelet therapy (aspirin and clopidogrel) more effective than standard antiplatelet therapy (aspirin alone) in patients receiving intravenous thrombolysis without increasing possible complications?
Design
This clinical trial was designed with 2 intervention groups, which are parallel, double-blind, randomized, phase 3 groups on 180 patients. The randomization site was used for randomization.
Settings and conduct
This study will be conducted in Ghaem Hospital of Mashhad on 180 patients who were treated with venous thrombolysis due to ischemic stroke, and people in the intervention group and the control group will receive two drugs for 21 days. Multiple evaluation of the patient up to 90 days will be done based on the modified ranking scale and finally the results will be checked. Except for the pharmacist, none of the participants, researchers and analysts will know about the drug or placebo until the end of the study, and the study is two-sided. will be blind
Participants/Inclusion and exclusion criteria
individuals over 18 years old with acute ischemic disabling stroke symptoms with NIHSS less than 5 that are not prohibited for receiving intravenous thrombolysis and double antiplatelet (aspirin and clopidogrel combination) will be included in the study.
Patients with atrial fibrillation rhythm, a patient who is already on double antiplatelet therapy, causing symptomatic intracranial hemorrhage after receiving intravenous thrombolysis, will not be included in the study.
Intervention groups
The first intervention group received aspirin 80 mg daily and placebo a daily dose for 21 days.
The second intervention group in our study is the dual therapy group, which receives 80 mg of aspirin daily and 75 mg of clopidogrel daily for 21 days.
Main outcome variables
Reduction of ischemic stroke recurrence
Reducing the disabilities of stroke patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230729058953N1
Registration date:2023-08-06, 1402/05/15
Registration timing:registered_while_recruiting
Last update:2023-08-06, 1402/05/15
Update count:0
Registration date
2023-08-06, 1402/05/15
Registrant information
Name
maryam panahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3852 5312
Email address
panahim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-01, 1402/05/10
Expected recruitment end date
2024-01-30, 1402/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
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
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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.
Exclusion criteria:
Patients with atrial fibrillation(AF) rhythm
A patient who is already on dual antiplatelet therapy
ICH (intracranial hemorrhage) symptomatic after receiving intravenous thrombolysis.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Mashhad University of Medical sciences
Street address
Ahmadabad Blvd, Ghaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9176755535
Approval date
2023-07-04, 1402/04/13
Ethics committee reference number
IR.MUMS.IRH.REC.1402.090
Health conditions studied
1
Description of health condition studied
ischemic cerebrovascular attack
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
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.