]>
IRCT20220516054874N19 IRCT 2024-08-03 Mashhad University of Medical Sciences The effect of Pentoxifylline on patients with coronary slow flow Investigating the effect of Pentoxifylline on echocardiography parameters in patients with coronary slow flow 2024-08-10 anticipated 48 Complete https://irct.ir/trial/78250 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The blocked randomization method is used. The volume of each block will be four. Then, the list of possible blocks is written and numbers assigned to them, for example (AABB(1)- BBAA(2)- BABA(3)- BAAB(4)), which will be 12 blocks according to the sample size of 48. Then, random numbers between 1 and 12 are selected according to the randomization site Randomaization.com and finally, the treatment allocation list is determined based on the random numbers. Sealed envelopes will be used to conceal allocation. A person not involved in sampling and data collection will prepare envelopes and randomize allocation, Blinding description: Blinding will performed using sealed envelopes. Due to the use of a placebo similar to the intervention treatment, the investigator and the participants will not be informed of the assigned treatment, and the analyst will also be unaware of the assigned treatment for the two groups. Finally, after analyzing the data, the researcher who prepared the packages will reveal the codes A and B. 3 Coronary slow flow syndrome. Intervention 1: Intervention group: Patients with slow coronary flow receiving common treatments (including aspirin, statins, beta-blockers and angiotensin-converting enzyme inhibitors) along with Pentoxifylline 400 mg three times a day for one month. Intervention 2: Control group: Patients with slow coronary flow receiving common treatments (including aspirin, statins, beta-blockers and angiotensin-converting enzyme inhibitors) along with placebo tablets three times a day for one month. Placebo will be prepared in the Pharmaceutics Laboratory of Mashhad School of Pharmacy. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Undecided - It is not yet known if there will be a plan to make this available
public Dr. Behzad Senobari
Imam Reza Hospital, Ahmadabad Blvd, Mashhad
Mashhad Iran (Islamic Republic of) 9177948564 0095 5138012739 senobarib4001@mums.ac.ir Mashhad University of Medical Sciences scientific Dr. Behzad Senobari
Imam Reza hospital, Ahmadabad Blvd, Mashhad
Mashhad Iran (Islamic Republic of) 9177948564 0095 5138012739 senobarib4001@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Diagnosing slow flow of coronary arteries based on angiography results corrected TIMI frame count of more than 27 frames per second Age older than 18 years old Consent to admission to the study 18 years no limit Both Previous use of pentoxifylline or other methylxanthine drugs Renal dysfunction with GFR < 20 Hepatic dysfunction Body mass index < 18.5 Pregnant or suspected pregnancy I20.8 Other forms of angina pectoris Treatment - Drugs Placebo Intervention group: Patients with slow coronary flow receiving common treatments (including aspirin, statins, beta-blockers and angiotensin-converting enzyme inhibitors) along with Pentoxifylline 400 mg three times a day for one month. Control group: Patients with slow coronary flow receiving common treatments (including aspirin, statins, beta-blockers and angiotensin-converting enzyme inhibitors) along with placebo tablets three times a day for one month. Placebo will be prepared in the Pharmaceutics Laboratory of Mashhad School of Pharmacy. Echocardiographic parameters including: Left ventricular ejection fraction, Left Atrial Volume Index, E/e' ratio, diastolic velocities. Timepoint: The beginning of the study and one months later. Method of measurement: Echocardiography. Mashhad University of Medical Sciences Approved 2024-07-01 Research Ethics Committee of Imam Reza Hospital Educational, Research and Treatment Center, Mashhad Imam Reza Hospital educational complex building, Imam Reza Hospital, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)