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

Phase 4

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

• Registration Number: CTRI/2016/08/007228
• Lead Sponsor: Torrent Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

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 < 60 kg,

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.

Study & Design

• Study Type: PMS
• Study Design: Not specified