NCT04330872

Brief Summary

Uncertainty remains regarding the impact of enteric-coated (EC) aspirin as it relates to the reduction of CV risk. We hypothesize that EC formulation based on the previous report may blunt aspirin response as evidenced by reduced Thromboxane A2 (TXA 2) levels in diabetic patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2019

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 26, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2020

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 2, 2020

Completed
Last Updated

April 2, 2020

Status Verified

March 1, 2020

Enrollment Period

4 months

First QC Date

March 23, 2020

Last Update Submit

March 30, 2020

Conditions

Stroke, Ischemic

Outcome Measures

Primary Outcomes (1)

  • Incidence of Aspirin non-responders.

    Aspirin nonresponsiveness is defined as a level of residual serum TXB2 associated with elevated thrombotic risk (\<99.0% inhibition or TXB2 \>3.1 ng/ml) after 3 daily aspirin doses

    At "Day 3"

Secondary Outcomes (1)

  • Incidence of Gastrointestinal bleeding consequent upon aspirin therapy.

    After three daily aspirin doses ( at "Day 3")

Study Arms (2)

Enteric coated Aspirin

ACTIVE COMPARATOR

EC aspirin loading dose 300mg followed by 100 mg (2 days). The study's total duration is 3 days.

Drug: Enteric Coated Aspirin Tablet

Plain Aspirin

PLACEBO COMPARATOR

Dispersible Aspirin loading dose 300mg followed by 75mg tablets (2 days) The study's total duration is 3 days.

Drug: Plain Aspirin

Interventions

Enteric Coated Aspirin TabletDRUG

Study participants will be assigned to receive either EC Aspirin and will be required to continue taking them throughout the study (three days).

Enteric coated Aspirin
Plain AspirinDRUG

Study participants will be assigned to receive either Plain Aspirin and will be required to continue taking them throughout the study (three days).

Plain Aspirin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Newly diagnosed ischemic stroke who are just about to start aspirin.
  • No prior history of cardiovascular morbidity (including ischemic heart disease, chronic kidney disease, peripheral vascular disease) 3-18- 75 years.
  • Patients with ischemic stroke who underwent reperfusion intervention (catheter-directed thrombolysis and/or thrombectomy) regardless of the time of presentation (i.e within or outside the therapeutic window as the managing stroke deem fit.

You may not qualify if:

  • Concomitant antiplatelet therapy (irrespective of the duration of the treatment).
  • Patients on any prostaglandins related medications (non-steroidal anti-inflammatory drugs, misoprostol, and other ant secretory drugs among others).
  • Any salicylate-containing supplements.
  • Patients on the NG tube will be excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamad Medical Corporation

Doha, 3050, Qatar

Location

Related Publications (2)

  • Elshafei MN, Imam Y, Alsaud AE, Chandra P, Parray A, Abdelmoneim MS, Obeidat K, Saeid R, Ali M, Ayadathil R, Mohamed MFH, Abdallah IM, Mohammed S, Akhtar N, Danjuma MI. The impact of enteric coating of aspirin on aspirin responsiveness in patients with suspected or newly diagnosed ischemic stroke: prospective cohort study: results from the (ECASIS) study. Eur J Clin Pharmacol. 2022 Nov;78(11):1801-1811. doi: 10.1007/s00228-022-03391-2. Epub 2022 Sep 19.

    PMID: 36121499DERIVED

  • Elshafei MN, Imam Y, Mohamed MFH, AlSaud AE, Ahmed MS, Obeidat K, Saeid R, Ali M, Abdallah IM, Parray AS, Danjuma MI. An investigation into the impact of enteric coated of aspirin in patients with newly diagnosed ischemic stroke (ECASIS). Medicine (Baltimore). 2020 May;99(20):e20307. doi: 10.1097/MD.0000000000020307.

    PMID: 32443379DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2020

First Posted

April 2, 2020

Study Start

August 26, 2019

Primary Completion

January 4, 2020

Study Completion

March 4, 2020

Last Updated

April 2, 2020

Record last verified: 2020-03

Locations

QA(1)