A clinical study to evaluate the efficacy, safety and tolerability of Picotamide chewable tablets 300mg vs. Aspirin tablets 325mg in patients requiring antiplatelet therapy.

A comparative, randomized, open label, multicentric, clinical study to evaluate the efficacy, safety and tolerability of Picotamide chewable tablets 300mg vs. Aspirin tablets 325mg in patients requiring antiplatelet therapy.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000588

Enrollment

200

Registered

2010-06-07

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D759- Disease of blood and blood-formingorgans, unspecified Health Condition 2: null- Patients requiring antiplatelet therapy

Interventions

Intervention1: Picotamide chewable 300mg tablets: Three times daily for 12 weeks Control Intervention1: Aspirin 325mg tablets: Once daily for 12 weeks

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients having signs and symptoms of any of the following: - diabetes/ obesity/ hypertension/ high blood cholesterol/ family history of heart disease, artery disease or blood disorders /cigarette smoking, tobacco chewing, alcohol consumption. 2.High platelet aggregation as per platelet aggregometry. 3.Written informed consent by patient participating in the trial.

Exclusion criteria

Exclusion criteria: ? Males or females < 18 years of age. ? Recent significant trauma or surgical interventions. ? Subjects will be excluded if they used NSAIDs within one week prior to the study, have renal insufficiency, inflammatory disorders such as rheumatologic conditions, autoimmune disorders, active infections, malignancy or if they are undergoing chemotherapy. ? Uncontrolled hypertension. ? History of bleeding disorders. ? Pregnant, possibly pregnant, or lactating females. ? Participation in clinical trial with an investigation drug within 30 days proceeding day one of this study. ? Any condition that in the opinion of the investigator, does not justify the patient?s inclusion in the study. ? History of hypersensitivity to the study drug or similar class of drug.

Design outcomes

Primary

Measure	Time frame
Chest painTimepoint: 0th day, 4th week, 8th week and 12th week;Chest painTimepoint: 0th day, 4th week, 8th week and 12th week;Chest painTimepoint: 0th day, 4th week, 8th week and 12th week;Chest painTimepoint: 0th day, 4th week, 8th week and 12th week;Chest painTimepoint: 0th day, 4th week, 8th week and 12th week;Chest painTimepoint: 0th day, 4th week, 8th week and 12th week;Chest painTimepoint: 0th day, 4th week, 8th week and 12th week;Chest painTimepoint: 0th day, 4th week, 8th week and 12th week;Chest painTimepoint: 0th day, 4th week, 8th week and 12th week;Chest painTimepoint: 0th day, 4th week, 8th week and 12th week	—

Measure

Time frame

Chest painTimepoint: 0th day, 4th week, 8th week and 12th week;Chest painTimepoint: 0th day, 4th week, 8th week and 12th week;Chest painTimepoint: 0th day, 4th week, 8th week and 12th week;Chest painTimepoint: 0th day, 4th week, 8th week and 12th week;Chest painTimepoint: 0th day, 4th week, 8th week and 12th week;Chest painTimepoint: 0th day, 4th week, 8th week and 12th week;Chest painTimepoint: 0th day, 4th week, 8th week and 12th week;Chest painTimepoint: 0th day, 4th week, 8th week and 12th week;Chest painTimepoint: 0th day, 4th week, 8th week and 12th week;Chest painTimepoint: 0th day, 4th week, 8th week and 12th week

—

Secondary

Measure	Time frame
Global AssessmentTimepoint: 12th week;Safety and TolerabilityTimepoint: 0th day, 4th week, 8th week and 12th week	—

Countries

India

Contacts

Public ContactDr Shailesh Singh

Ajanta Pharma Ltd, Advent

shailesh.singh@ajantapharma.com02266062111

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026