Post marketing surveillance study of Prax A 75 (fixed dose combination capsule containing prasugrel 10mg and aspirin 75mg)

A post marketing surveillance study of Prax A 75 (fixed dose combination capsule containing prasugrel 10mg and aspirin 75mg) in patients with Acute Coronary Syndrome (ACS) who are to be managed with Percutaneous Coronary Intervention (PCI).

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2016/08/007228

Enrollment

700

Registered

2016-08-31

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-18

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

Conditions

Health Condition 1: I249- Acute ischemic heart disease, unspecified

Interventions

Intervention1: fixed dose combination capsule containing prasugrel 10mg and aspirin 75mg: FDC of prasugrel 10mg and aspirin 75mg Orally one capsule a day for 52 week Control Intervention1: Not Applica

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and female adult patients not below 18 years of age. 2. Patients diagnosed with ACS to be managed with PCI & who as per treating physician’s judgment need prasugrel and aspirin as dual antipletelet therapy for maintenance.

Exclusion criteria

Exclusion criteria: 1. Patients with known hypersensitivity to any component of this product or to other salicylates or nonsteroidal anti-inflammatory drugs (a patient may have developed anaphylaxis, angioedema, asthma, rhinitis or urticaria induced by aspirin or other NSAIDs), 2. Patients with history of or active pathological bleeding, 3. Patient with history of stroke or Transient Ischaemic Attack (TIA), 4. Patient with severe hepatic impairment (Child-Pugh class C), or severe renal impairment or severe cardiac failure, 5. Patients >75 years of age, 6. Patients with weight 7. Patient with nasal polyps associated with asthma (high risk of severe sensitivity reactions), 8. Patient with active peptic ulceration or a past history of ulceration or dyspepsia, 9. Patient with haemophilia or other haemorrhagic disorder (including thrombocytopenia) as there is an increased risk of bleeding, 10. Patient with concurrent anticoagulant therapy, 11. Pregnant or lactating females. 12. Female patients who are of childbearing potential and who were neither using a reliable contraceptive method nor surgically sterilized within 3 weeks prior to screening visit and not willing to use contraceptive methods during the study period.

Design outcomes

Primary

Measure	Time frame
Safety and tolerabilityTimepoint: 4 weeks (±7 days), 12 weeks (±7 days), 24 weeks (±7 days), 36 weeks (±7 days) and 52 weeks (±7 days)	—

Secondary

Measure	Time frame
NILTimepoint: NIL	—

Countries

India

Contacts

Public ContactDr. Amarinder Singh

Torrent Pharmaceuticals Ltd

AmarinderSingh@torrentpharma.com079-23969100

Outcome results

None listed

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