Pakistan Aspirin Foundation initiates landmark primary prevention study named as A4P Trial


 Prof. Javed Akram selected as the Principal Investigator

Pakistan Aspirin Foundation initiates
landmark primary prevention study
named as A4P Trial

About 19,000 patients to be enrolled at fifty centers
all over Pakistan and study will last 4-5 years

Training of investigators as per GCP Guidelines planned
at Peshawar, Rawalpindi-Islamabad, Lahore and Karachi

From our correspondent

MULTAN: Pakistan Aspirin Foundation has initiated a primary prevention trial which has been named as A4P trial (Aspirin in Primary Prevention of Cardiovascular Events in Pakistani Population). This landmark trial was formally inaugurated by Prof. Mustafa Kamal Pasha Vice Chancellor of Nishtar Medical University Multan on October 24th 2018. The meeting was largely attended by eminent physicians, cardiologists from all over the country who were in Multan in connection with CARDIOCON 2018. Prof. Javed Akram a noted researcher and Vice Chancellor of University of Health Sciences is the Principal Investigator of the study with Dr. Muhammad Zaman Khan as Co-Principal Investigator while Mr. Waqas Latif will look after the statistical analysis of the data.

Speaking at the occasion Prof. Mustafa Kamal Pasha commended the efforts of Pakistan Aspirin Foundation and Principal Investigator Prof. Javed Akram. He hoped that this study will generate lot of useful data in local population. We as surgeons do use Aspirin to prevent Deep Vein Thrombosis and it does work well, he remarked.

A4P (Aspirin for Primary Prevention of cardiovascular events in Pakistani Population) was formally
inaugurated by Prof. Mustafa Kamal Pasha Vice Chancellor of Nishtar Medical University during
the Aspirin Session at cardiology conference at Multan on November 24th 2018. Group photograph
taken on this occasion shows Prof. Mustafa Kamal Pasha with Primary Investigator of the
study Prof. Javed Akram and other senior cardiologists from all over Pakistan.

Prof. Javed Akram an eminent physician and former President of Pakistan Aspirin Foundation was selected as the Principal Investigator of this important trial at a meeting of the Experts Committee of Pakistan Aspirin Foundation at a meeting held on October 19th. Presenting details of the study protocol Prof. Javed Akram said that the safety and efficacy of Aspirin in secondary prevention is well established but there have been some conflicting reports as regards its use in primary prevention. Different trials has given different results. Hence, we planned this study to generate local data in Pakistani population to prove that Aspirin remains a wonder drug. It can prevent lot of morbidity and mortality even in primary prevention in high risk patients. The trial has been named as A4P Trial which will be conducted at about fifty centers all over the country in the four provinces besides Azad Kashmir and Gilgit Baltistan. It is planned to enroll over nineteen thousand patients between the ages of 40-80 years at about fifty centers.

The likely investigators and the centers are now being identified. In this Randomized Double Blind Placebo Controlled Trial, patients with no morbidities and those suffering from hypertension, dyslipidemia, diabetes mellitus (one or more conditions) will be enrolled. Enteric coated Aspirin 75mg will be used in the study. The selected investigators will be given training at Peshawar, Rawalpindi-Islamabad, Lahore and Karachi and the trial will be conducted following Good Clinical Practice Guidelines. The study will be continued for four to five years.

Giving details of Composite Primary and Secondary endpoints as well as Individual secondary endpoints and outcome measures, Prof. Javed Akram mentioned the following:

  1. Death from CV causes i.e. myocardial infarction, stroke and other cardiovascular causes.
  2. Non-fatal stroke (ischemic or hemorrhagic)
  3. Non-fatal MI
  4. Transient Ischemic Attack (TIA)
  5. Angina Pectoris
  6. Arteriosclerotic disease requiring surgery or intervention
  7. Death from causes other than cardiovascular disease
  8. Any cause of death
  9. Serious extra cranial hemorrhage requiring transfusion or hospitalization.

Production of enteric coated Aspirin and production of matched placebo is being planned. Application is being sent to the Drug Regulatory Authority of Pakistan for necessary approval for producing the placebo. Approval of the study protocol will be taken from the National Bioethics Committee formed by the Government of Pakistan. All the study sites will be audited after every three months. Detailed work plan is being formulated and once the formalities are completed, enrollment of the patients will be started.

Prof. Javed Akram further stated that they have looked at different Meta-analysis and Systematic Reviews. We have also looked at the recent large randomized trials related to primary prevention i.e. ARRIVE study, ACCEPT-D which is still ongoing, ASCEND study and ASPREE trial. We have carefully studied the results of these studies before planning this primary prevention trial. We feel that our patient’s population is a bit different and we need to generate local data for use of Aspirin in primary prevention.

It will be a multispecialty study involving physicians, cardiologists, surgeons, neurologists, neurosurgeons, orthopedic surgeons, obstetricians and gynecologists besides family physicians. Informed consent of the patients who will be enrolled in the study will be taken. Consent form is being prepared and it will be translated in all the regional languages. Adverse Drug Reporting will be ensured. Higher Education Commission, Government of Pakistan, Pakistan Science Foundation and University of Health Sciences are being approached to provide funding for this study. We also intend to look into Aspirin resistance. Once the study is completed we hope to publish the findings. A lot of papers are planned to be published based on this data in peer reviewed medical journals at home and overseas, Prof. Javed Akram concluded.

After his presentation, views from the distinguished participants were invited who gave some very useful suggestions regarding the age of patients to be enrolled, ethical approval, preparation of the consent form and its translation in different regional languages to ensure that the participants can understand the objective of the study were made which were later incorporated in the study protocol.

Mr. Shaukat Ali Jawaid General Secretary of Pakistan Aspirin Foundation who will be coordinating between different centers and investigators thanked the eminent medical personalities for gracing the occasion with their presence and extending whole hearted support for this primary prevention study. He specially thanked Prof. Mustafa Kamal Pasha Vice Chancellor of Nishtar Medical University for accepting the invitation of Pakistan Aspirin Foundation to preside the meeting and formally inaugurate the launch of the study.

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